Study Stopped
Lack of benefit and safety concern
Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)
ALTITUDE
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality
2 other identifiers
interventional
8,606
37 countries
776
Brief Summary
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney. AMENDMENT 4 RATIONALE (MARCH 2012) : Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Oct 2007
Longer than P75 for phase_3 type-2-diabetes-mellitus
776 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 24, 2007
CompletedFirst Posted
Study publicly available on registry
October 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
March 18, 2014
CompletedApril 21, 2014
April 1, 2014
5.3 years
October 24, 2007
February 3, 2014
April 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)
Occurrence was defined as the first event of the following composite primary endpoint: * Cardiovascular (CV) death * Resuscitated sudden death * Non-fatal myocardial infarction (MI) * Non-fatal stroke * Unplanned hospitalization for heart failure (HF) * Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. * Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Time from randomization to the first event (Maximum 50 months)
Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase)
Time from randomization to the first event (Maximum 50 months)
Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase)
Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase)
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase)
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase)
ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase)
To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase)
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase)
Time from randomization to the first event (Maximum 50 months)
Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase)
Occurrence was defined as the first event of the following composite primary endpoint: * Cardiovascular (CV) death * Resuscitated sudden death * Non-fatal myocardial infarction (MI) * Non-fatal stroke * Unplanned hospitalization for heart failure (HF) * Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. * Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With Cardiovascular (CV) Death (Extension Phase)
from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With Resuscitated Sudden Death (Extension Phase)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)
Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase)
ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase)
To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With All Cause Mortality (Extension Phase)
from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Secondary Outcomes (4)
Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase)
Time from randomization to the first event (Maximum 50 months)
Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase)
Time from randomization to the first event (Maximum 50 months)
Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Other Outcomes (4)
Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase)
Time from randomization to the first event (Maximum 50 months)
Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase)
Baseline, Month 6 , last measurement (maximum at 50 months)
Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase)
Baseline to Month 3 and Month 6
- +1 more other outcomes
Study Arms (2)
Aliskiren
EXPERIMENTALIn Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment
Placebo
PLACEBO COMPARATORIn Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes and at least one of the following:
- Macroalbuminuria and an eGFR ≥30 mL/min/1.73 m2
- Microalbuminuria and a reduced kidney function (eGFR eGFR ≥30 and \<60 mL/min/1.73 m2)
- A history of CV disease (previous MI, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (eGFR ≥30 and \<60 mL/min/1.73 m2)
- Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both.
You may not qualify if:
- Type 1 diabetes mellitus
- Cardiovascular event or procedure ≤ 3 months prior to Visit 1
- Unstable serum creatinine
- Hypertension: Mean sitting systolic blood pressure (msSBP) ≥ 135 and \< 170 mmHg or Mean sitting diastolic blood pressure (msDBP) ≥ 85 and \< 110 mmHg unless treated with at least 3 anti-hypertensive medications
- Hypertension msSBP ≥ 170 or msDBP ≥ 110 mmHg
- Baseline Serum Potassium \> 5.0 mmol/L
- Patients who are treated with two renin-angiotensin-aldosterone-system-blockers
- Patients with NYHA class III or IV heart failure
- Known renal artery stenosis
- Previous randomization into the AVOID trial (CSPP100C2201)
- \- Aliskiren or aliskiren containing fixed combination products must not be used
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (776)
Novartis Investigative Site
Birmingham, Alabama, 35209, United States
Novartis Investigative Site
Birmingham, Alabama, 35235, United States
Novartis Investigative Site
Huntsville, Alabama, 35801, United States
Novartis Investigative Site
Mobile, Alabama, 36608, United States
Novartis Investigative Site
Mobile, Alabama, 36617, United States
Novartis Investigative Site
Montgomery, Alabama, 36106, United States
Novartis Investigative Site
Muscle Shoals, Alabama, 35662, United States
Novartis Investigative Site
Peoria, Arizona, 85381, United States
Novartis Investigative Site
Phoenix, Arizona, 85032, United States
Novartis Investigative Site
Tucson, Arizona, 85712, United States
Novartis Investigative Site
Tucson, Arizona, 85741, United States
Novartis Investigative Site
Fayetteville, Arkansas, 72703, United States
Novartis Investigative Site
Burlingame, California, 94010, United States
Novartis Investigative Site
Fullerton, California, 92835, United States
Novartis Investigative Site
Huntington Beach, California, 92648, United States
Novartis Investigative Site
Oakland, California, 94609, United States
Novartis Investigative Site
Pasadena, California, 91101, United States
Novartis Investigative Site
Riverside, California, 92501, United States
Novartis Investigative Site
Spring Valley, California, 91978-1522, United States
Novartis Investigative Site
Torrance, California, 90502, United States
Novartis Investigative Site
Walnut Creek, California, 94598, United States
Novartis Investigative Site
Denver, Colorado, 80209, United States
Novartis Investigative Site
Bridgeport, Connecticut, 06610, United States
Novartis Investigative Site
Aventura, Florida, 33180, United States
Novartis Investigative Site
Boca Raton, Florida, 33433, United States
Novartis Investigative Site
Fort Lauderdale, Florida, 33311, United States
Novartis Investigative Site
Hollywood, Florida, 33021, United States
Novartis Investigative Site
Jacksonville, Florida, 32204, United States
Novartis Investigative Site
Jacksonville, Florida, 32205, United States
Novartis Investigative Site
Jacksonville, Florida, 32209, United States
Novartis Investigative Site
Jacksonville, Florida, 32216, United States
Novartis Investigative Site
Lauderdale Lakes, Florida, 33313, United States
Novartis Investigative Site
Pensacola, Florida, 32504, United States
Novartis Investigative Site
Plantation, Florida, 33324, United States
Novartis Investigative Site
West Palm Beach, Florida, 33401, United States
Novartis Investigative Site
Atlanta, Georgia, 30309, United States
Novartis Investigative Site
Augusta, Georgia, 30904, United States
Novartis Investigative Site
Augusta, Georgia, 30909, United States
Novartis Investigative Site
Cumming, Georgia, 30041, United States
Novartis Investigative Site
Honolulu, Hawaii, 96813, United States
Novartis Investigative Site
Honolulu, Hawaii, 96814, United States
Novartis Investigative Site
Champaign, Illinois, 61820, United States
Novartis Investigative Site
Lake Zurich, Illinois, 60047, United States
Novartis Investigative Site
Peoria, Illinois, 61615, United States
Novartis Investigative Site
Topeka, Kansas, 66606, United States
Novartis Investigative Site
Louisville, Kentucky, 40202, United States
Novartis Investigative Site
Metairie, Louisiana, 70006, United States
Novartis Investigative Site
Slidell, Louisiana, 70458, United States
Novartis Investigative Site
Baltimore, Maryland, 21204, United States
Novartis Investigative Site
Burlington, Massachusetts, 01803, United States
Novartis Investigative Site
Haverhill, Massachusetts, 01830, United States
Novartis Investigative Site
Jamaica Plain, Massachusetts, 02130, United States
Novartis Investigative Site
Natick, Massachusetts, 01760, United States
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747, United States
Novartis Investigative Site
Waltham, Massachusetts, 02154, United States
Novartis Investigative Site
Worcester, Massachusetts, 01609, United States
Novartis Investigative Site
Ann Arbor, Michigan, 48109, United States
Novartis Investigative Site
Detroit, Michigan, 48202, United States
Novartis Investigative Site
Detroit, Michigan, 48236, United States
Novartis Investigative Site
Kalamazoo, Michigan, 49048, United States
Novartis Investigative Site
Livonia, Michigan, 48154, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55404, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55455, United States
Novartis Investigative Site
Saint Louis Park, Minnesota, 55416, United States
Novartis Investigative Site
Belzoni, Mississippi, 39038, United States
Novartis Investigative Site
Gulfport, Mississippi, 39501, United States
Novartis Investigative Site
Jackson, Mississippi, 39209, United States
Novartis Investigative Site
Springfield, Missouri, 65807, United States
Novartis Investigative Site
St Louis, Missouri, 63110-1093, United States
Novartis Investigative Site
St Louis, Missouri, 63141, United States
Novartis Investigative Site
Fremont, Nebraska, 68025, United States
Novartis Investigative Site
Omaha, Nebraska, 68131, United States
Novartis Investigative Site
Dover, New Hampshire, 03820-2403, United States
Novartis Investigative Site
Princeton Junction, New Jersey, 08550, United States
Novartis Investigative Site
Albuquerque, New Mexico, 87106, United States
Novartis Investigative Site
Albany, New York, 12206, United States
Novartis Investigative Site
Rochester, New York, 14607, United States
Novartis Investigative Site
Cincinnati, Ohio, 45236, United States
Novartis Investigative Site
Cleveland, Ohio, 44115, United States
Novartis Investigative Site
Lyndhurst, Ohio, 44124, United States
Novartis Investigative Site
Norman, Oklahoma, 73069, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112, United States
Novartis Investigative Site
Tulsa, Oklahoma, 74133, United States
Novartis Investigative Site
Allentown, Pennsylvania, 18103, United States
Novartis Investigative Site
Lancaster, Pennsylvania, 17604, United States
Novartis Investigative Site
Lansdale, Pennsylvania, 19446, United States
Novartis Investigative Site
Melrose Park, Pennsylvania, 19027, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, 19138, United States
Novartis Investigative Site
Wyomissing, Pennsylvania, 19610, United States
Novartis Investigative Site
Warwick, Rhode Island, 02886, United States
Novartis Investigative Site
Aiken, South Carolina, 29801, United States
Novartis Investigative Site
Charleston, South Carolina, 29425, United States
Novartis Investigative Site
Columbia, South Carolina, 29201, United States
Novartis Investigative Site
Greenville, South Carolina, 29605, United States
Novartis Investigative Site
Orangeburg, South Carolina, 29115, United States
Novartis Investigative Site
Collierville, Tennessee, 38017, United States
Novartis Investigative Site
Amarillo, Texas, 79106, United States
Novartis Investigative Site
Austin, Texas, 78731, United States
Novartis Investigative Site
Dallas, Texas, 75226, United States
Novartis Investigative Site
Dallas, Texas, 75231, United States
Novartis Investigative Site
Dallas, Texas, 75235, United States
Novartis Investigative Site
Dallas, Texas, 75390, United States
Novartis Investigative Site
Houston, Texas, 77030, United States
Novartis Investigative Site
Irving, Texas, 75039, United States
Novartis Investigative Site
McAllen, Texas, 78501, United States
Novartis Investigative Site
North Richland Hills, Texas, 76180, United States
Novartis Investigative Site
Plano, Texas, 75024, United States
Novartis Investigative Site
San Antonio, Texas, 78207, United States
Novartis Investigative Site
San Antonio, Texas, 78218, United States
Novartis Investigative Site
San Antonio, Texas, 78229-4801, United States
Novartis Investigative Site
Temple, Texas, 76508-0002, United States
Novartis Investigative Site
Bennington, Vermont, 05201, United States
Novartis Investigative Site
Burlington, Vermont, 05401, United States
Novartis Investigative Site
Alexandria, Virginia, 22304-2315, United States
Novartis Investigative Site
Burke, Virginia, 22015, United States
Novartis Investigative Site
Renton, Washington, 98055, United States
Novartis Investigative Site
Charleston, West Virginia, 25301, United States
Novartis Investigative Site
Appleton, Wisconsin, 54911, United States
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1120AAC, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1405BCH, Argentina
Novartis Investigative Site
Caba, Buenos Aires, 1428, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1181ACH, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1280AEB, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1408INH, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1416DRJ, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1425AST, Argentina
Novartis Investigative Site
Florida, Buenos Aires, B1602BPD, Argentina
Novartis Investigative Site
Lanús, Buenos Aires, B8000XAV, Argentina
Novartis Investigative Site
Ramos Mejía, Buenos Aires, B1704ETD, Argentina
Novartis Investigative Site
Zárate, Buenos Aires, 2800, Argentina
Novartis Investigative Site
Corrientes, Corrientes Province, W3400, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, 5000, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, X5000AAW, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, X5000EVQ, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, X5000FGG, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, X5000IUG, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, X5000JHQ, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, X5009BSN, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, X5016KEH, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000AII, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000CXH, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DFD, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2001ODA, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S200CVD, Argentina
Novartis Investigative Site
Santa Fe, Santa Fe Province, S3000FNF, Argentina
Novartis Investigative Site
Santa Fe, Santa Fe Province, S3000FSO, Argentina
Novartis Investigative Site
Santa Fe, Santa Fe Province, S3000FVA, Argentina
Novartis Investigative Site
Vienna, Austria, A-1220, Austria
Novartis Investigative Site
Bregenz, A-6900, Austria
Novartis Investigative Site
Feldkirch, 6807, Austria
Novartis Investigative Site
Graz, 8036, Austria
Novartis Investigative Site
Innsbruck, INNSBRUCK, Austria
Novartis Investigative Site
Salzburg, A-5020, Austria
Novartis Investigative Site
Vienna, 1030, Austria
Novartis Investigative Site
Vienna, 1090, Austria
Novartis Investigative Site
Vienna, A-1130, Austria
Novartis Investigative Site
Bonheiden, 2820, Belgium
Novartis Investigative Site
Bruges, 8000, Belgium
Novartis Investigative Site
Brussels, 1070, Belgium
Novartis Investigative Site
Brussels, 1200, Belgium
Novartis Investigative Site
Brussels, 9100, Belgium
Novartis Investigative Site
Charleroi, 6000, Belgium
Novartis Investigative Site
De Pinte, 9840, Belgium
Novartis Investigative Site
Edegem, 2650, Belgium
Novartis Investigative Site
Genk, 3600, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Hasselt, 3500, Belgium
Novartis Investigative Site
Kortrijk, 8500, Belgium
Novartis Investigative Site
La Louvière, 7100, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Roeselare, 8800, Belgium
Novartis Investigative Site
Ronse, 9600, Belgium
Novartis Investigative Site
Seraing, 4100, Belgium
Novartis Investigative Site
Sint-Gillis-Waas, 9170, Belgium
Novartis Investigative Site
Turnhout, 2300, Belgium
Novartis Investigative Site
Vilvoorde, 1800, Belgium
Novartis Investigative Site
Willebroek, 2830, Belgium
Novartis Investigative Site
Fortaleza, Ceará, 60120-021, Brazil
Novartis Investigative Site
Fortaleza, Ceará, 60430-370, Brazil
Novartis Investigative Site
Vitória, Espírito Santo, 29040-091, Brazil
Novartis Investigative Site
Salvador, Estado de Bahia, 40050-410, Brazil
Novartis Investigative Site
Juiz de Fora, Minas Gerais, 36036-110, Brazil
Novartis Investigative Site
Belém, Pará, 66073-000, Brazil
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20020-020, Brazil
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Novartis Investigative Site
Campinas, São Paulo, 13060-904, Brazil
Novartis Investigative Site
Campinas, São Paulo, 13083-190, Brazil
Novartis Investigative Site
Marília, São Paulo, 17519-030, Brazil
Novartis Investigative Site
Santos, São Paulo, 11045-904, Brazil
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15090-000, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 04023-900, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 05403-000, Brazil
Novartis Investigative Site
Sorocaba, São Paulo, 18030-210, Brazil
Novartis Investigative Site
Edmonton, Alberta, T5J 3N4, Canada
Novartis Investigative Site
Edmonton, Alberta, T5N 3Y6, Canada
Novartis Investigative Site
Vancouver, British Columbia, V6E 1M7, Canada
Novartis Investigative Site
Winnipeg, Manitoba, R2V 4W3, Canada
Novartis Investigative Site
Winnipeg, Manitoba, R3E 3P4, Canada
Novartis Investigative Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1E 4J8, Canada
Novartis Investigative Site
Brampton, Ontario, L6Z 4N5, Canada
Novartis Investigative Site
Burlington, Ontario, L7M 4Y1, Canada
Novartis Investigative Site
Cambridge, Ontario, N1R 6V6, Canada
Novartis Investigative Site
Courtice, Ontario, L1E 3C3, Canada
Novartis Investigative Site
Etobicoke, Ontario, M9R 4E1, Canada
Novartis Investigative Site
London, Ontario, N6A 4G5, Canada
Novartis Investigative Site
North Bay, Ontario, P1B 2H3, Canada
Novartis Investigative Site
Oakville, Ontario, L6H 3P1, Canada
Novartis Investigative Site
Oshawa, Ontario, L1J 2K1, Canada
Novartis Investigative Site
Ottawa, Ontario, K1H 7W9, Canada
Novartis Investigative Site
Scarborough Village, Ontario, M1H 3G4, Canada
Novartis Investigative Site
Thornhill, Ontario, L4J 8L7, Canada
Novartis Investigative Site
Toronto, Ontario, M4G 3E8, Canada
Novartis Investigative Site
Toronto, Ontario, M4N 3M5, Canada
Novartis Investigative Site
Toronto, Ontario, M5C 2T2, Canada
Novartis Investigative Site
Toronto, Ontario, N6G 4X8, Canada
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2H1, Canada
Novartis Investigative Site
Mirabel, Quebec, J7J 2K8, Canada
Novartis Investigative Site
Montreal, Quebec, H1T 2M4, Canada
Novartis Investigative Site
Pointe-Claire, Quebec, H9R 4S3, Canada
Novartis Investigative Site
Québec, Quebec, G1G 3Y8, Canada
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5, Canada
Novartis Investigative Site
Sainte-Foy, Quebec, G1W 4R4, Canada
Novartis Investigative Site
Sherbrooke, Quebec, J1G 5K2, Canada
Novartis Investigative Site
Ste-Foy, Quebec, G1V 4G2, Canada
Novartis Investigative Site
Trois-Rivières, Quebec, G8Z 3R9, Canada
Novartis Investigative Site
Saskatoon, Saskatchewan, S7H 5M3, Canada
Novartis Investigative Site
Ouest-Montreal, H2W1R7, Canada
Novartis Investigative Site
Beijing, Beijing Municipality, 100044, China
Novartis Investigative Site
Beijing, Beijing Municipality, 100083, China
Novartis Investigative Site
Beijing, Beijing Municipality, 100730, China
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400016, China
Novartis Investigative Site
Chongqing, Chongqing Municipality, China
Novartis Investigative Site
Fuzhou, Fujian, 350025, China
Novartis Investigative Site
Guangzhou, Guangdong, 510180, China
Novartis Investigative Site
Shijiazhuang, Hebei, 050051, China
Novartis Investigative Site
Harbin, Heilongjiang, 150001, China
Novartis Investigative Site
Harbin, Heilongjiang, 150086, China
Novartis Investigative Site
Wuhan, Hubei, 430030, China
Novartis Investigative Site
Changsha, Hunan, 410008, China
Novartis Investigative Site
Changsha, Hunan, 410011, China
Novartis Investigative Site
Nanjing, Jiangsu, 210006, China
Novartis Investigative Site
Nanjing, Jiangsu, 210008, China
Novartis Investigative Site
Nanjing, Jiangsu, 210009, China
Novartis Investigative Site
Nanjing, Jiangsu, 210029, China
Novartis Investigative Site
Suzhou, Jiangsu, 215004, China
Novartis Investigative Site
Dalian, Liaoning, 116011, China
Novartis Investigative Site
Shenyang, Liaoning, 110003, China
Novartis Investigative Site
Qingdao, Shandong, 266011, China
Novartis Investigative Site
Xi’an, Shanxi, 710032, China
Novartis Investigative Site
Xi’an, Shanxi, 710061, China
Novartis Investigative Site
Chengdu, Sichuan, 610041, China
Novartis Investigative Site
Kunming, Yunnan, 650101, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310003, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310009, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310013, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310016, China
Novartis Investigative Site
Beijing, 100028, China
Novartis Investigative Site
Beijing, 100029, China
Novartis Investigative Site
Beijing, 100034, China
Novartis Investigative Site
Beijing, 100088, China
Novartis Investigative Site
Beijing, 100176, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Chengdu, 610072, China
Novartis Investigative Site
Chongqing, 400038, China
Novartis Investigative Site
Dalian, China
Novartis Investigative Site
Guangzhou, 510000, China
Novartis Investigative Site
Shanghai, 200003, China
Novartis Investigative Site
Shanghai, 200025, China
Novartis Investigative Site
Shanghai, 200031, China
Novartis Investigative Site
Shanghai, 200233, China
Novartis Investigative Site
Tianjin, 300052, China
Novartis Investigative Site
Tianjin, 300142, China
Novartis Investigative Site
Bogotá, Colombia
Novartis Investigative Site
Cali, Colombia
Novartis Investigative Site
Florida Blanca, Colombia
Novartis Investigative Site
Medellín, Colombia
Novartis Investigative Site
České Budějovice, Czech Republic, 370 87, Czechia
Novartis Investigative Site
Prague, Czech Republic, 128 02, Czechia
Novartis Investigative Site
Brno, 61300, Czechia
Novartis Investigative Site
Brno-Bohunice, 639 01, Czechia
Novartis Investigative Site
Ostrava, 702 00, Czechia
Novartis Investigative Site
Pardubice, 53002, Czechia
Novartis Investigative Site
Písek, 397 01, Czechia
Novartis Investigative Site
Prague, 128 08, Czechia
Novartis Investigative Site
Prague 4 - Krc, 14059, Czechia
Novartis Investigative Site
Prague 5 - Motol, 15112, Czechia
Novartis Investigative Site
Copenhagen NV, Denmark, DK-2400, Denmark
Novartis Investigative Site
Roskilde, Denmark, DK-4000, Denmark
Novartis Investigative Site
Aalborg, DK-9100, Denmark
Novartis Investigative Site
Aarhus, DK-8000, Denmark
Novartis Investigative Site
Frederiksberg, DK-2000, Denmark
Novartis Investigative Site
Gentofte Municipality, DK-2820, Denmark
Novartis Investigative Site
Hillerød, DK-3400, Denmark
Novartis Investigative Site
Hvidovre, 2650, Denmark
Novartis Investigative Site
Slagelse, DK-4200, Denmark
Novartis Investigative Site
Svendborg, DK-5700, Denmark
Novartis Investigative Site
Oulu, Finland, 90100, Finland
Novartis Investigative Site
Pori, Finland, 28120, Finland
Novartis Investigative Site
Ekenäs, 10600, Finland
Novartis Investigative Site
Helsinki, 00250, Finland
Novartis Investigative Site
Hyvinkää, FIN-05850, Finland
Novartis Investigative Site
Kajaani, FIN-87140, Finland
Novartis Investigative Site
Kuopio, FIN-70211, Finland
Novartis Investigative Site
Lohja, FIN-08200, Finland
Novartis Investigative Site
OYS, FIN-90029, Finland
Novartis Investigative Site
Tampere, 33520, Finland
Novartis Investigative Site
Valkeakoski, 37600, Finland
Novartis Investigative Site
Besançon, 25030, France
Novartis Investigative Site
Bondy, 93143, France
Novartis Investigative Site
Corbeil-Essonnes, 91100, France
Novartis Investigative Site
Grenoble, 38043, France
Novartis Investigative Site
La Rochelle, 17019, France
Novartis Investigative Site
Lagny-sur-Marne, 77405, France
Novartis Investigative Site
Limoges, 87042, France
Novartis Investigative Site
Lyon, 69394, France
Novartis Investigative Site
Lyon, 69437, France
Novartis Investigative Site
Paris, 75181, France
Novartis Investigative Site
Paris, 75877, France
Novartis Investigative Site
Poitiers, 86021, France
Novartis Investigative Site
Aschaffenburg, 63739, Germany
Novartis Investigative Site
Aschaffenburg, 63741, Germany
Novartis Investigative Site
Aßlar, 35614, Germany
Novartis Investigative Site
Bad Oeynhausen, 32545, Germany
Novartis Investigative Site
Barsinghausen, 30890, Germany
Novartis Investigative Site
Bensheim, 64625, Germany
Novartis Investigative Site
Berlin, 13055, Germany
Novartis Investigative Site
Berlin, 13597, Germany
Novartis Investigative Site
Berlin, 14193, Germany
Novartis Investigative Site
Bonn, 53105, Germany
Novartis Investigative Site
Bottrop, 46242, Germany
Novartis Investigative Site
Bremen, 28277, Germany
Novartis Investigative Site
Bretten, 75015, Germany
Novartis Investigative Site
Cloppenburg, 49661, Germany
Novartis Investigative Site
Dippoldiswalde, 01744, Germany
Novartis Investigative Site
Dresden, 01127, Germany
Novartis Investigative Site
Dresden, 01307, Germany
Novartis Investigative Site
Düsseldorf, 40210, Germany
Novartis Investigative Site
Essen, 45127, Germany
Novartis Investigative Site
Essen, 45134, Germany
Novartis Investigative Site
Essen, 45138, Germany
Novartis Investigative Site
Fuldatal, 34233, Germany
Novartis Investigative Site
Göttingen, 37075, Germany
Novartis Investigative Site
Hagen, 58095, Germany
Novartis Investigative Site
Hamburg, 22335, Germany
Novartis Investigative Site
Hamburg, 22393, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Heidelberg, 69120, Germany
Novartis Investigative Site
Heilbronn, 74072, Germany
Novartis Investigative Site
Heilbronn, 74076, Germany
Novartis Investigative Site
Ingelheim, 55218, Germany
Novartis Investigative Site
Jena, 07743, Germany
Novartis Investigative Site
Kassel, 34117, Germany
Novartis Investigative Site
Krefeld, 47798, Germany
Novartis Investigative Site
Magdeburg, 39120, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Messkirch, 88605, Germany
Novartis Investigative Site
Muehldorf Am Inn, 84453, Germany
Novartis Investigative Site
Neuwied, 56564, Germany
Novartis Investigative Site
Offenbach, 63065, Germany
Novartis Investigative Site
Rehburg-Loccum, 31547, Germany
Novartis Investigative Site
Riesa, 01587, Germany
Novartis Investigative Site
Saint Ingbert - Oberwuerzbach, 66386, Germany
Novartis Investigative Site
Schauenburg-Elgershausen, 34270, Germany
Novartis Investigative Site
Schwabenheim, 55270, Germany
Novartis Investigative Site
Ursensollen, 92289, Germany
Novartis Investigative Site
Wetter, 58300, Germany
Novartis Investigative Site
Wiehl, 51674, Germany
Novartis Investigative Site
Wiesbaden, 65183, Germany
Novartis Investigative Site
Würzburg, 97072, Germany
Novartis Investigative Site
Alexandroupoli, Greece, GR 68 100, Greece
Novartis Investigative Site
Athens, Greece, GR 115 21, Greece
Novartis Investigative Site
Athens, Greece, GR 115 27, Greece
Novartis Investigative Site
Athens, Greece, GR 11527, Greece
Novartis Investigative Site
Thessaloniki, Greece, 57001, Greece
Novartis Investigative Site
Thessaloniki, Greece, GR 546 39, Greece
Novartis Investigative Site
Athens, GR 115 22, Greece
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Athens - GR, 10676, Greece
Novartis Investigative Site
Ioannina, GR 45500, Greece
Novartis Investigative Site
Pátrai, 26500, Greece
Novartis Investigative Site
Piraeurs, GR 184 54, Greece
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01001, Guatemala
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01010, Guatemala
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01011, Guatemala
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01015, Guatemala
Novartis Investigative Site
Baja, 6500, Hungary
Novartis Investigative Site
Balatonfüred, 8230, Hungary
Novartis Investigative Site
Budapest, 1062, Hungary
Novartis Investigative Site
Budapest, 1083, Hungary
Novartis Investigative Site
Budapest, 1085, Hungary
Novartis Investigative Site
Budapest, 1096, Hungary
Novartis Investigative Site
Budapest, 1115, Hungary
Novartis Investigative Site
Budapest, H-1032, Hungary
Novartis Investigative Site
Debrecen, 4004, Hungary
Novartis Investigative Site
Debrecen, 4032, Hungary
Novartis Investigative Site
Gyula, 5703, Hungary
Novartis Investigative Site
Kaposvár, 7400, Hungary
Novartis Investigative Site
Miskolc, 3526, Hungary
Novartis Investigative Site
Pécs, 7324, Hungary
Novartis Investigative Site
Szeged, 6720, Hungary
Novartis Investigative Site
Zalaegerszeg, 8900, Hungary
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500001, India
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500012, India
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500018, India
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India, 500034, India
Novartis Investigative Site
Ahmedabad, Gujarat, 380014, India
Novartis Investigative Site
Bangalore, Karnataka, 560054, India
Novartis Investigative Site
Banglaore, Karnataka, 560038, India
Novartis Investigative Site
Mangalore, Karnataka, 575001, India
Novartis Investigative Site
Kochi, Kerala, 682 026, India
Novartis Investigative Site
Mumbai, Maharashtra, 400008, India
Novartis Investigative Site
Pune, Maharashtra, 411011, India
Novartis Investigative Site
Pune, Maharashtra, 411030, India
Novartis Investigative Site
Chennai, Tamil Nadu, 600013, India
Novartis Investigative Site
Vellore, Tamil Nadu, 632004, India
Novartis Investigative Site
Bangalore, 560 034, India
Novartis Investigative Site
Chennai, 600010, India
Novartis Investigative Site
Chennai, 600086, India
Novartis Investigative Site
Hyderabad, 500 063, India
Novartis Investigative Site
Kolkota, 700020, India
Novartis Investigative Site
New Delhi, 110 029, India
Novartis Investigative Site
L’Aquila, AQ, 67100, Italy
Novartis Investigative Site
Bergamo, BG, 24128, Italy
Novartis Investigative Site
Belluno, BL, 32100, Italy
Novartis Investigative Site
Bologna, BO, 40138, Italy
Novartis Investigative Site
Campobasso, CB, 86100, Italy
Novartis Investigative Site
Caserta, CE, 81100, Italy
Novartis Investigative Site
Chieti, CH, 66100, Italy
Novartis Investigative Site
Cuneo, CN, 12100, Italy
Novartis Investigative Site
Cosenza, CS, 87100, Italy
Novartis Investigative Site
Catanzaro, CZ, 88100, Italy
Novartis Investigative Site
Cona, FE, 44100, Italy
Novartis Investigative Site
Foggia, FG, 71100, Italy
Novartis Investigative Site
Florence, FI, 50134, Italy
Novartis Investigative Site
Arenzano, GE, 16011, Italy
Novartis Investigative Site
Genova, GE, 16132, Italy
Novartis Investigative Site
Pozzilli, IS, 86077, Italy
Novartis Investigative Site
Lecco, LC, 23900, Italy
Novartis Investigative Site
Monza, MB, 20900, Italy
Novartis Investigative Site
Milan, MI, 20123, Italy
Novartis Investigative Site
Milan, MI, 20132, Italy
Novartis Investigative Site
Milan, MI, 20146, Italy
Novartis Investigative Site
Milan, MI, 20157, Italy
Novartis Investigative Site
Passirana Di Rho, MI, 20017, Italy
Novartis Investigative Site
Palermo, PA, 90127, Italy
Novartis Investigative Site
Perugia, PG, 06100, Italy
Novartis Investigative Site
Pisa, PI, 56124, Italy
Novartis Investigative Site
Pisa, PI, 56126, Italy
Novartis Investigative Site
Pordenone, PN, 33170, Italy
Novartis Investigative Site
Parma, PR, 43100, Italy
Novartis Investigative Site
Casorate Primo, PV, 27022, Italy
Novartis Investigative Site
Pavia, PV, 27100, Italy
Novartis Investigative Site
Stradella, PV, 27049, Italy
Novartis Investigative Site
Ravenna, RA, 48100, Italy
Novartis Investigative Site
Roma, RM, 00122, Italy
Novartis Investigative Site
Roma, RM, 00133, Italy
Novartis Investigative Site
Roma, RM, 00157, Italy
Novartis Investigative Site
Roma, RM, 00161, Italy
Novartis Investigative Site
Roma, RM, 00163, Italy
Novartis Investigative Site
Roma, RM, 00186, Italy
Novartis Investigative Site
Roma, RM, 00189, Italy
Novartis Investigative Site
Cava de' Tirreni, SA, 84013, Italy
Novartis Investigative Site
Mercato San Severino, SA, 84085, Italy
Novartis Investigative Site
Salerno, SA, 84125, Italy
Novartis Investigative Site
Siena, SI, 53100, Italy
Novartis Investigative Site
Olbia, SS, 07026, Italy
Novartis Investigative Site
Sassari, SS, 07100, Italy
Novartis Investigative Site
Torino, TO, 10126, Italy
Novartis Investigative Site
Torino, TO, 10128, Italy
Novartis Investigative Site
Torino, TO, 10154, Italy
Novartis Investigative Site
Vittorio Veneto, TV, 31029, Italy
Novartis Investigative Site
San Daniele del Friuli, UD, 33038, Italy
Novartis Investigative Site
Udine, UD, 33100, Italy
Novartis Investigative Site
Venezia, VE, 30174, Italy
Novartis Investigative Site
Verona, VR, 37126, Italy
Novartis Investigative Site
Isernia, 86170, Italy
Novartis Investigative Site
Napoli, 80131, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, 451-8511, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, 455-8530, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, 460-0001, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, 462-0802, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, 462-0825, Japan
Novartis Investigative Site
Asahi, Chiba, 289-2511, Japan
Novartis Investigative Site
Kasuga, Fukuoka, 816-0864, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, 800-0296, Japan
Novartis Investigative Site
Kōriyama, Fukushima, 963-8851, Japan
Novartis Investigative Site
Asahikawa, Hokkaido, 078-8211, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 003-0023, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 060-0033, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 060-8648, Japan
Novartis Investigative Site
Toride, Ibaraki, 302-0022, Japan
Novartis Investigative Site
Takamatsu, Kagawa-ken, 7600076, Japan
Novartis Investigative Site
Aira, Kagoshima-ken, 899-5431, Japan
Novartis Investigative Site
Isehara, Kanagawa, 259-1131, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, 210-0852, Japan
Novartis Investigative Site
Yatsushiro, Kumamoto, 866-8660, Japan
Novartis Investigative Site
Kyoto, Kyoto, 612-8555, Japan
Novartis Investigative Site
Kyoto, Kyoto, 615-0035, Japan
Novartis Investigative Site
Sendai, Miyagi, 980-8574, Japan
Novartis Investigative Site
Suwa, Nagano, 392-8510, Japan
Novartis Investigative Site
Ōita, Oita Prefecture, 870-0039, Japan
Novartis Investigative Site
Ōita, Oita Prefecture, 870-0192, Japan
Novartis Investigative Site
Okayama, Okayama-ken, 700-8558, Japan
Novartis Investigative Site
Okayama, Okayama-ken, 701-1192, Japan
Novartis Investigative Site
Takatsuki, Osaka, 569-1096, Japan
Novartis Investigative Site
Toyonaka, Osaka, 561-0871, Japan
Novartis Investigative Site
Yao, Osaka, 581-0011, Japan
Novartis Investigative Site
Tokorozawa, Saitama, 351-1151, Japan
Novartis Investigative Site
Ohtsu-city, Shiga, 520-2192, Japan
Novartis Investigative Site
Shimizu, Shizuoka, 411-8611, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8655, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0002, Japan
Novartis Investigative Site
Takaoka, Toyama, 933-0955, Japan
Novartis Investigative Site
Kaunas, 50009, Lithuania
Novartis Investigative Site
Klaipėda, 92304, Lithuania
Novartis Investigative Site
Vilnius, LT-08661, Lithuania
Novartis Investigative Site
Vilnius, Lithuania
Novartis Investigative Site
Almelo, Netherlands, 7609 PP, Netherlands
Novartis Investigative Site
Alkmaar, 1851 JD, Netherlands
Novartis Investigative Site
Amersfoort, 3800 BM, Netherlands
Novartis Investigative Site
Amsterdam, 1061 AE, Netherlands
Novartis Investigative Site
Apeldoorn, 7334 DZ, Netherlands
Novartis Investigative Site
Arnhem, 6815 AD, Netherlands
Novartis Investigative Site
Breda, 4818 CK, Netherlands
Novartis Investigative Site
Delft, 2625 AD, Netherlands
Novartis Investigative Site
Den Helder, 1782 GZ, Netherlands
Novartis Investigative Site
Deventer, 7416 SE, Netherlands
Novartis Investigative Site
Doetinchem, 7009 BL, Netherlands
Novartis Investigative Site
Dordrecht, 3318AT, Netherlands
Novartis Investigative Site
Eindhoven, 5623 EJ, Netherlands
Novartis Investigative Site
Eindhoven, 5631 BM, Netherlands
Novartis Investigative Site
Goes, 4462 RA, Netherlands
Novartis Investigative Site
Groningen, 9713 GZ, Netherlands
Novartis Investigative Site
Heerlen, 6419 PC, Netherlands
Novartis Investigative Site
Hoogeveen, 7909 AA, Netherlands
Novartis Investigative Site
Hoogwoud, 1718 BG, Netherlands
Novartis Investigative Site
Losser, 7581 BV, Netherlands
Novartis Investigative Site
Meppel, 7943 KA, Netherlands
Novartis Investigative Site
Nieuwegein, 3435 CM, Netherlands
Novartis Investigative Site
Oude Pekela, 9665 AR, Netherlands
Novartis Investigative Site
Rotterdam, 3015 CE, Netherlands
Novartis Investigative Site
Rotterdam, 3045 PM, Netherlands
Novartis Investigative Site
Rotterdam, 3083 AN, Netherlands
Novartis Investigative Site
Tiel, 4002 WP, Netherlands
Novartis Investigative Site
Utrecht, 3508 GA, Netherlands
Novartis Investigative Site
Venlo, 5912 BL, Netherlands
Novartis Investigative Site
Woerden, 3443 GG, Netherlands
Novartis Investigative Site
Zwijndrecht, NL-3331 LZ, Netherlands
Novartis Investigative Site
Zwolle, 8025 AB, Netherlands
Novartis Investigative Site
Fredrikstad, Norway, 1607, Norway
Novartis Investigative Site
Horten, Norway, 3191, Norway
Novartis Investigative Site
Skien, Norway, 3722, Norway
Novartis Investigative Site
Bergen, 5013, Norway
Novartis Investigative Site
Hønefoss, 3515, Norway
Novartis Investigative Site
Oslo, 0160, Norway
Novartis Investigative Site
Skedsmokorset, 2020, Norway
Novartis Investigative Site
Spikkestad, 3430, Norway
Novartis Investigative Site
Stavanger, 4011, Norway
Novartis Investigative Site
Svelvik, 3060, Norway
Novartis Investigative Site
Tromsø, NO-9038, Norway
Novartis Investigative Site
Trondheim, NO-7011, Norway
Novartis Investigative Site
Tønsberg, 3103, Norway
Novartis Investigative Site
Bellavista, Lima region, Callao 02, Peru
Novartis Investigative Site
Lima Cercado, Lima region, 01, Peru
Novartis Investigative Site
San Borja, Lima region, 41, Peru
Novartis Investigative Site
San Isidro, Lima region, 27, Peru
Novartis Investigative Site
San Martín de Porres, Lima region, 31, Peru
Novartis Investigative Site
Santiago de Surco, Lima region, 33, Peru
Novartis Investigative Site
Coimbra, Portugal, 3000-075, Portugal
Novartis Investigative Site
Lisbon, Portugal, 1495-005, Portugal
Novartis Investigative Site
Almada, 2801-951, Portugal
Novartis Investigative Site
Amadora, 2720-276, Portugal
Novartis Investigative Site
Linda a Velha, 2799-523, Portugal
Novartis Investigative Site
Lisbon, 1169-024, Portugal
Novartis Investigative Site
Lisbon, 1250-203, Portugal
Novartis Investigative Site
Lisbon, 1649-035, Portugal
Novartis Investigative Site
Matosinhos Municipality, 4454-509, Portugal
Novartis Investigative Site
Portimão, 8500-388, Portugal
Novartis Investigative Site
Porto, 4200-319, Portugal
Novartis Investigative Site
Santa Maria da Feira, 4520-211, Portugal
Novartis Investigative Site
Santarém, 2000-153, Portugal
Novartis Investigative Site
Ponce, 00716, Puerto Rico
Novartis Investigative Site
Ponce, 00733-1471, Puerto Rico
Novartis Investigative Site
Singapore, Singapore, 168752, Singapore
Novartis Investigative Site
Singapore, Singapore, 169608, Singapore
Novartis Investigative Site
Singapore, Singapore, 308433, Singapore
Novartis Investigative Site
Singapore, 119074, Singapore
Novartis Investigative Site
Singapore, 159964, Singapore
Novartis Investigative Site
Bratislava, Slovak Republic, 826 06, Slovakia
Novartis Investigative Site
Košice, Slovak Republic, 040 22, Slovakia
Novartis Investigative Site
Žilina, Slovak Republic, 010 01, Slovakia
Novartis Investigative Site
Bratislava, Slovakia, 811 08, Slovakia
Novartis Investigative Site
Martin, Slovakia, 03601, Slovakia
Novartis Investigative Site
Nitra, Slovakia, 949 01, Slovakia
Novartis Investigative Site
Banksa Bystrica, SK 97 517, Slovakia
Novartis Investigative Site
Bratislava, 812 72, Slovakia
Novartis Investigative Site
Bratislava, 81369, Slovakia
Novartis Investigative Site
Bratislava, 833 48, Slovakia
Novartis Investigative Site
Bratislava, 851 07, Slovakia
Novartis Investigative Site
Košice, 040 01, Slovakia
Novartis Investigative Site
Lučenec, 98439, Slovakia
Novartis Investigative Site
Ľubochňa, SK 03491, Slovakia
Novartis Investigative Site
Piešťany, 921 01, Slovakia
Novartis Investigative Site
Prievidza, 971 01, Slovakia
Novartis Investigative Site
Trstená, 549 16, Slovakia
Novartis Investigative Site
Somerset West, Western Cape, 7130, South Africa
Novartis Investigative Site
Cape Town, 7925, South Africa
Novartis Investigative Site
Durban, 4001, South Africa
Novartis Investigative Site
Durban, 4030, South Africa
Novartis Investigative Site
Durban, 4052, South Africa
Novartis Investigative Site
Durban, 4110, South Africa
Novartis Investigative Site
Gauteng, South Africa
Novartis Investigative Site
Johannesburg, 2196, South Africa
Novartis Investigative Site
Port Elizabeth, 6001, South Africa
Novartis Investigative Site
Pretoria, 0002, South Africa
Novartis Investigative Site
Busan, Busan, 602-739, South Korea
Novartis Investigative Site
Ansan, Gyeonggi-do, 425-801, South Korea
Novartis Investigative Site
Anyang-si, Gyeonggi-do, 431-070, South Korea
Novartis Investigative Site
Seoul, Korea, 110 744, South Korea
Novartis Investigative Site
Seoul, Korea, 120-752, South Korea
Novartis Investigative Site
Seoul, Korea, 135-710, South Korea
Novartis Investigative Site
Bundang, Seongnam, 463-707, South Korea
Novartis Investigative Site
Daejeon, 301-747, South Korea
Novartis Investigative Site
Incheon, 400-712, South Korea
Novartis Investigative Site
Pusan, 614-735, South Korea
Novartis Investigative Site
Seoul, 135-720, South Korea
Novartis Investigative Site
Seoul, 136 705, South Korea
Novartis Investigative Site
Seoul, 137-701, South Korea
Novartis Investigative Site
Seoul, 152-703, South Korea
Novartis Investigative Site
Seoul, 156-707, South Korea
Novartis Investigative Site
Taegu, 700 - 721, South Korea
Novartis Investigative Site
Cadiz, Andalusia, 11010, Spain
Novartis Investigative Site
El Puerto de Santa María, Andalusia, 11500, Spain
Novartis Investigative Site
Granada, Andalusia, 18014, Spain
Novartis Investigative Site
Jerez de la Frontera, Andalusia, 11407, Spain
Novartis Investigative Site
Málaga, Andalusia, 29010, Spain
Novartis Investigative Site
Málaga, Andalusia, 29018, Spain
Novartis Investigative Site
Sanlúcar de Barrameda, Andalusia, 11540, Spain
Novartis Investigative Site
Seville, Andalusia, 41009, Spain
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Novartis Investigative Site
Sabadell, Barcelona, 08208, Spain
Novartis Investigative Site
Donostia / San Sebastian, Basque Country, 20014, Spain
Novartis Investigative Site
Plentzia, Basque Country, 48620, Spain
Novartis Investigative Site
Villabona, Basque Country, 20150, Spain
Novartis Investigative Site
Zumarraga, Basque Country, 20700, Spain
Novartis Investigative Site
Aranda de Duero, Castille and León, 09400, Spain
Novartis Investigative Site
Miranda de Ebro, Castille and León, 09200, Spain
Novartis Investigative Site
Alcázar de San Juan, Castille-La Mancha, 13600, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08025, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08905, Spain
Novartis Investigative Site
Girona, Catalonia, 17007, Spain
Novartis Investigative Site
La Pobla Llarga, Catalonia, 46670, Spain
Novartis Investigative Site
Llança, Catalonia, 17490, Spain
Novartis Investigative Site
Manresa, Catalonia, 08240, Spain
Novartis Investigative Site
Mollet del Vallès, Catalonia, 08100, Spain
Novartis Investigative Site
Rubí, Catalonia, 08191, Spain
Novartis Investigative Site
Santa Coloma de Gramanet, Catalonia, 08923, Spain
Novartis Investigative Site
Tàrrega, Catalonia, 25300, Spain
Novartis Investigative Site
Vic, Catalonia, 08500, Spain
Novartis Investigative Site
Mérida, Extremadura, 06800, Spain
Novartis Investigative Site
A Coruña, Galicia, 15010, Spain
Novartis Investigative Site
Begonte, Galicia, 27373, Spain
Novartis Investigative Site
Ferrol, Galicia, 15405, Spain
Novartis Investigative Site
Pontevedra, Galicia, 36071, Spain
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706, Spain
Novartis Investigative Site
Vigo, Galicia, 36200, Spain
Novartis Investigative Site
Alfaro, La Rioja, 26540, Spain
Novartis Investigative Site
Logroño, La Rioja, 26005, Spain
Novartis Investigative Site
Alcorcón, Madrid, 28922, Spain
Novartis Investigative Site
Arganda, Madrid, 28500, Spain
Novartis Investigative Site
Civdad Real, Madrid, 13002, Spain
Novartis Investigative Site
Madrid, Madrid, 28034, Spain
Novartis Investigative Site
Madrid, Madrid, 28035, Spain
Novartis Investigative Site
Madrid, Madrid, 28040, Spain
Novartis Investigative Site
Madrid, Madrid, 28041, Spain
Novartis Investigative Site
Madrid, Madrid, 28046, Spain
Novartis Investigative Site
Madrid, Madrid, 28770, Spain
Novartis Investigative Site
Murcia, Madrid, 30007, Spain
Novartis Investigative Site
Oviedo, Principality of Asturias, 33006, Spain
Novartis Investigative Site
Oviedo, Principality of Asturias, 33008, Spain
Novartis Investigative Site
Oviedo, Principality of Asturias, 33010, Spain
Novartis Investigative Site
Alaquàs, Valencia, 46970, Spain
Novartis Investigative Site
Alicante, Valencia, 03004, Spain
Novartis Investigative Site
Alzira, Valencia, 46600, Spain
Novartis Investigative Site
Benidorm, Valencia, 03550, Spain
Novartis Investigative Site
Port de Sagunt, Valencia, 46520, Spain
Novartis Investigative Site
Quart de Poblet, Valencia, 46930, Spain
Novartis Investigative Site
Valencia, Valencia, 46010, Spain
Novartis Investigative Site
Valencia, Valencia, 46011, Spain
Novartis Investigative Site
Valencia, Valencia, 46014, Spain
Novartis Investigative Site
Valencia, Valencia, 46017, Spain
Novartis Investigative Site
Valencia, Valencia, 46019, Spain
Novartis Investigative Site
Xixona, Valencia, 03100, Spain
Novartis Investigative Site
Hospitalet de Llbregat, 08902, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Spain
Novartis Investigative Site
Gothenburg, SE-412 55, Sweden
Novartis Investigative Site
Helsingborg, 251 87, Sweden
Novartis Investigative Site
Karlstad, 651 85, Sweden
Novartis Investigative Site
Malmo, 21152, Sweden
Novartis Investigative Site
Rättvik, 79530, Sweden
Novartis Investigative Site
Stenstorp, SE-521 60, Sweden
Novartis Investigative Site
Uppsala, 751 85, Sweden
Novartis Investigative Site
Varberg, s-432 81, Sweden
Novartis Investigative Site
Estavayer-le-Lac, CH, 1470, Switzerland
Novartis Investigative Site
Bolligen, Switzerland, 3065, Switzerland
Novartis Investigative Site
Winterthur, Switzerland, 8400, Switzerland
Novartis Investigative Site
Ascona, Switzerland
Novartis Investigative Site
Bern, 3010, Switzerland
Novartis Investigative Site
Bruderholz, 4101, Switzerland
Novartis Investigative Site
Fribourg, 1700, Switzerland
Novartis Investigative Site
La Chaux-de-Fonds, 2300, Switzerland
Novartis Investigative Site
Lausanne, 1011, Switzerland
Novartis Investigative Site
Lugano, 6900, Switzerland
Novartis Investigative Site
Lugano, 6903, Switzerland
Novartis Investigative Site
Renens, 1020, Switzerland
Novartis Investigative Site
Sankt Gallen, 9007, Switzerland
Novartis Investigative Site
Schaffhausen, 8200, Switzerland
Novartis Investigative Site
Zurich, 8091, Switzerland
Novartis Investigative Site
Yungkang, Tainan, 710, Taiwan
Novartis Investigative Site
Taichung, Taiwan, 40705, Taiwan
Novartis Investigative Site
Taipei, Taiwan, 114, Taiwan
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Changhua, 500, Taiwan
Novartis Investigative Site
Kaohsiung City, 807, Taiwan
Novartis Investigative Site
Niaosong Township, 83301, Taiwan
Novartis Investigative Site
Taichung, Taiwan
Novartis Investigative Site
Taichung County, Taiwan
Novartis Investigative Site
Taipei, 10002, Taiwan
Novartis Investigative Site
Bangkok, 10330, Thailand
Novartis Investigative Site
Bangkok, 10400, Thailand
Novartis Investigative Site
Bangkok, 10700, Thailand
Novartis Investigative Site
Chiang Mai, 50200, Thailand
Novartis Investigative Site
Ankara, Turkey, 06590, Turkey (Türkiye)
Novartis Investigative Site
Altunizade, 34662, Turkey (Türkiye)
Novartis Investigative Site
Ankara, 06100, Turkey (Türkiye)
Novartis Investigative Site
Gaziantep, 27070, Turkey (Türkiye)
Novartis Investigative Site
Izmir, 35040, Turkey (Türkiye)
Novartis Investigative Site
Izmir, 35340, Turkey (Türkiye)
Novartis Investigative Site
Kocaeli, 41380, Turkey (Türkiye)
Novartis Investigative Site
High Wycombe, Buckinghamshire, HP11 2TT, United Kingdom
Novartis Investigative Site
Truro, Cornwall, TR1 3LJ, United Kingdom
Novartis Investigative Site
Paignton, Devon, TQ4 5LA, United Kingdom
Novartis Investigative Site
Cornwall, England, PL23 1DT, United Kingdom
Novartis Investigative Site
Welwyn Garden City, Hertfordshire, AL7 4HQ, United Kingdom
Novartis Investigative Site
Gravesend, Kent, DA1 24JW, United Kingdom
Novartis Investigative Site
Glasgow, Scotland, G12 8TA, United Kingdom
Novartis Investigative Site
East Horsley, Surrey, KT24 6QT, United Kingdom
Novartis Investigative Site
Crawley, West Sussex, RH10 7DX, United Kingdom
Novartis Investigative Site
Bath, BA2 3HT, United Kingdom
Novartis Investigative Site
Cardiff, CF14 4XN, United Kingdom
Novartis Investigative Site
Cardiff, CF5 4AD, United Kingdom
Novartis Investigative Site
Glasgow, G11 6NT, United Kingdom
Novartis Investigative Site
Glasgow, G21 3UW, United Kingdom
Novartis Investigative Site
Irvine, KA12 0AY, United Kingdom
Novartis Investigative Site
Lancashire, FY3 7EN, United Kingdom
Novartis Investigative Site
Lancashire, FY4 3AD, United Kingdom
Novartis Investigative Site
London, NW10 7NS, United Kingdom
Novartis Investigative Site
London, SE1 9RT, United Kingdom
Novartis Investigative Site
London, SW17 0QT, United Kingdom
Novartis Investigative Site
Manchester, M13 9NT, United Kingdom
Novartis Investigative Site
Merseyside, L7 8PX, United Kingdom
Novartis Investigative Site
Rugby, CV21 5 PX, United Kingdom
Novartis Investigative Site
Vale of Glanmorgan, CF63 4AR, United Kingdom
Novartis Investigative Site
Wrexham, LL13 7TD, United Kingdom
Novartis Investigative Site
Puerto Ordaz and San Felix, Bolívar, 8050, Venezuela
Novartis Investigative Site
Valencia, Carabobo, 2001, Venezuela
Novartis Investigative Site
Caracas, Distrito Federal, 1010, Venezuela
Novartis Investigative Site
Caracas, Distrito Federal, 1020, Venezuela
Novartis Investigative Site
Caracas, Distrito Federal, 1040, Venezuela
Novartis Investigative Site
Caracas, Distrito Federal, 1080-A, Venezuela
Novartis Investigative Site
Caracas, Distrito Federal, 1100, Venezuela
Novartis Investigative Site
Caracas, Miranda, 1060, Venezuela
Related Publications (6)
Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17.
PMID: 40526444DERIVEDHeerspink HJL, Jongs N, Schloemer P, Little DJ, Brinker M, Tasto C, Karpefors M, Wheeler DC, Bakris G, Perkovic V, Nkulikiyinka R, Rossert J, Gasparyan SB. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023 Dec 1;34(12):2025-2038. doi: 10.1681/ASN.0000000000000243. Epub 2023 Oct 24.
PMID: 37872654DERIVEDMalachias MVB, Jhund PS, Claggett BL, Wijkman MO, Bentley-Lewis R, Chaturvedi N, Desai AS, Haffner SM, Parving HH, Prescott MF, Solomon SD, De Zeeuw D, McMurray JJV, Pfeffer MA. NT-proBNP by Itself Predicts Death and Cardiovascular Events in High-Risk Patients With Type 2 Diabetes Mellitus. J Am Heart Assoc. 2020 Oct 20;9(19):e017462. doi: 10.1161/JAHA.120.017462. Epub 2020 Sep 23.
PMID: 32964800DERIVEDHeerspink HJ, Persson F, Brenner BM, Chaturvedi N, Brunel P, McMurray JJ, Desai AS, Solomon SD, Pfeffer MA, Parving HH, de Zeeuw D. Renal outcomes with aliskiren in patients with type 2 diabetes: a prespecified secondary analysis of the ALTITUDE randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Apr;4(4):309-17. doi: 10.1016/S2213-8587(15)00469-6. Epub 2016 Jan 14.
PMID: 26774608DERIVEDParving HH, Brenner BM, McMurray JJ, de Zeeuw D, Haffner SM, Solomon SD, Chaturvedi N, Persson F, Desai AS, Nicolaides M, Richard A, Xiang Z, Brunel P, Pfeffer MA; ALTITUDE Investigators. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med. 2012 Dec 6;367(23):2204-13. doi: 10.1056/NEJMoa1208799. Epub 2012 Nov 3.
PMID: 23121378DERIVEDLambers Heerspink HJ, Perkovic V, de Zeeuw D. Renal and cardio-protective effects of direct renin inhibition: a systematic literature review. J Hypertens. 2009 Dec;27(12):2321-31. doi: 10.1097/HJH.0b013e3283310f92.
PMID: 19727007DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
- STUDY CHAIR
Novartis
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2007
First Posted
October 26, 2007
Study Start
October 1, 2007
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
April 21, 2014
Results First Posted
March 18, 2014
Record last verified: 2014-04