Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction
A Multicenter Study to Evaluate Safety and Tolerability in Patients With Chronic Heart Failure and Reduced Ejection Fraction From PARADIGM-HF Receiving Open Label LCZ696
2 other identifiers
interventional
1,980
40 countries
392
Brief Summary
The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
Typical duration for phase_3
392 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
First Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
August 27, 2014
CompletedStudy Start
First participant enrolled
October 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2017
CompletedResults Posted
Study results publicly available
February 20, 2019
CompletedFebruary 20, 2019
February 1, 2019
3.2 years
August 25, 2014
December 18, 2018
February 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696
The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.
From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.
Study Arms (1)
LCZ696
EXPERIMENTALAngiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
Interventions
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
Eligibility Criteria
You may qualify if:
- Written informed consent for the extension must be obtained before any assessment is performed.
- Patients who have completed PARADIGM-HF (protocol CLCZ696B2314) and are able to be safely enrolled into the open-label trial as judged by the investigator.
You may not qualify if:
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to LCZ696
- Known history of angioedema
- Requirement of simultaneous treatment with both ACEIs and ARBs
- Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
- Symptomatic hypotension and/or a SBP \< 100 mmHg at Visit 1 (screening)
- Estimated GFR \< 30 mL/min/1.73m\^2 as measured by the simplified MDRD formula at Visit 1 (screening)
- Presence of bilateral renal artery stenosis
- Serum potassium \> 5.2 mmol/L at Visit 1 (screening)
- Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Any condition, not identified in the protocol, that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (394)
Novartis Investigative Site
Huntsville, Alabama, 35801, United States
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Muscle Shoals, Alabama, 35662, United States
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Little Rock, Arkansas, 72204, United States
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Oceanside, California, 92056, United States
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Palm Springs, California, 92262, United States
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San Diego, California, 92161, United States
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Santa Rosa, California, 95405, United States
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Boynton Beach, Florida, 33472-2952, United States
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Des Moines, Iowa, 50314, United States
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Covington, Louisiana, 70433, United States
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Columbia, Maryland, 21044, United States
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Saginaw, Michigan, 48601, United States
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Minneapolis, Minnesota, 55417, United States
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Fremont, Nebraska, 68025, United States
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New York, New York, 10032, United States
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Rosedale, New York, 11422, United States
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Raleigh, North Carolina, 27610, United States
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Marion, Ohio, 43302, United States
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Rapid City, South Dakota, 57701, United States
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Dallas, Texas, 75235, United States
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Dallas, Texas, 75251, United States
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Livingston, Texas, 77351, United States
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Spokane, Washington, 99204, United States
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Waukesha, Wisconsin, 53188, United States
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CABA, Buenos Aires, C1221ADC, Argentina
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Ciudad Autonoma de Bs As, Buenos Aires, C1119ACN, Argentina
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Mar del Plata, Buenos Aires, B7600FZN, Argentina
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Quilmes, Buenos Aires, B1878DVB, Argentina
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CABA, Buenos Aires F.D., C1179AAB, Argentina
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San Salvador de Jujuy, Jujuy Province, Y4600ABF, Argentina
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Salta, Salta Province, A4406BPF, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, S2000AII, Argentina
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Rosario, Santa Fe Province, S2000QID, Argentina
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Corrientes, W3400CLH, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5000AAX, Argentina
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Córdoba, X5016KET, Argentina
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Formosa, P3600, Argentina
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Formosa, P3634XAR, Argentina
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Mendoza, M5500CHC, Argentina
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San Luis, D5702JRS, Argentina
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Santa Fe, S3000EOZ, Argentina
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Santa Fe, S3000FWO, Argentina
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Santiago del Estero, G4200AQK, Argentina
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Brasschaat, 2930, Belgium
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Ghent, 9000, Belgium
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La Louvière, 7100, Belgium
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Leuven, 3000, Belgium
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Ronse, 9600, Belgium
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Salvador, Estado de Bahia, 41810-010, Brazil
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Brasília, Federal District, 70390-903, Brazil
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Goiânia, Goiás, 74223-130, Brazil
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Goiânia, Goiás, 74605 050, Brazil
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Goiânia, Goiás, 74823-470, Brazil
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São Luís, Maranhão, 65020-070, Brazil
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Uberlândia, Mg-cep, 38411-186, Brazil
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Belo Horizonte, Minas Gerais, 20180-090, Brazil
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Belo Horizonte, Minas Gerais, 30150-221, Brazil
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Belém, Pará, 66087-660, Brazil
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Recife, Pernambuco, 52051-380, Brazil
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Rio de Janeiro, Rio de Janeiro, 22280-020, Brazil
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Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
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Marília, São Paulo, 17515-000, Brazil
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Ribeirão Preto, São Paulo, 14055-370, Brazil
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Santo André, São Paulo, 09190-615, Brazil
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São José do Rio Preto, São Paulo, 15015-750, Brazil
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São Paulo, São Paulo, 01323 000, Brazil
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São Paulo, São Paulo, 05403-000, Brazil
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Votuporanga, São Paulo, 15500-003, Brazil
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Haskovo, 6300, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Shumen, 9700, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1606, Bulgaria
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Varna, 9010, Bulgaria
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Victoria, British Columbia, V8R4R2, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Kitchener, Ontario, N2M 5N4, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Weston, Ontario, M9N 1W4, Canada
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Lévis, Quebec, G6V 4Z5, Canada
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St-Georges Beauce, Quebec, G5Y 4T8, Canada
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Temuco, Región de la Araucanía, 4780000, Chile
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Beroun, Czech Republic, 266 01, Czechia
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Brandýs nad Labem, Czech Republic, 250 01, Czechia
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Liberec V Kristianova, Czech Republic, 460 05, Czechia
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Randers, 8930, Denmark
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Frankfurt, 60488, Germany
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Hamburg, 22291, Germany
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Hamburg, 22765, Germany
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Huy / OT Anderbeck, 38836, Germany
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Ingelheim, 55218, Germany
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Kelkheim, 65779, Germany
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Köthen, 06366, Germany
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Künzelsau, 74653, Germany
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Leipzig, 04109, Germany
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Leipzig, 04129, Germany
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Leipzig, 04315, Germany
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Löhne, 32584, Germany
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Muehlheim An Der Ruhr, 45468, Germany
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Mühldorf, 84453, Germany
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Offenbach, 63073, Germany
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Wermsdorf, 04779, Germany
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Weyhe, 28844, Germany
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Debrecen, 4032, Hungary
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Nyiregyháza, 4400, Hungary
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Szekszárd, 7100, Hungary
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Székesfehérvár, H-8000, Hungary
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Zalaegerszeg, 8900, Hungary
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Guntur, Andhra Pradesh, 522001, India
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Ahmedabad, Gujarat, 380 051, India
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Ahmedabad, Gujarat, 380054, India
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Anand, Gujarat, 388325, India
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Surat, Gujarat, 395 002, India
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Surat, Gujarat, 395002, India
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Vadodara, Gujarat, 390015, India
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Mumbai, Maharashtra, 400012, India
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Nagpur, Maharashtra, 400012, India
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Nagpur, Maharashtra, 440010, India
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Nashik, Maharashtra, 422 005, India
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Nashik, Maharashtra, 422002, India
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Nashik, Maharashtra, 422005, India
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Pune, Maharashtra, 411 011, India
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Pune, Maharashtra, 411011, India
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Delhi, National Capital Territory of Delhi, 110080, India
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Ludhiana, Punjab, 141002, India
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Bikaner, Rajasthan, 334003, India
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Hyderabad, Telangana, 500 063, India
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Indore, 452014, India
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Ashkelon, 78278, Israel
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Hadera, 38100, Israel
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Haifa, 3436212, Israel
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Haifa, 3525408, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 49100, Israel
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Rehovot, 76100, Israel
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Safed, 13100, Israel
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Aosta, AO, 11100, Italy
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Cortona, AR, 52044, Italy
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Bergamo, BG, 24127, Italy
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Treviglio, BG, 24047, Italy
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Cosenza, CS, 87100, Italy
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Cona, FE, 44100, Italy
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Genova, GE, 16132, Italy
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Pozzilli, IS, 86077, Italy
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Lido di Camaiore, LU, 55041, Italy
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Milazzo, ME, 98057, Italy
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Pisa, PI, 56126, Italy
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Pescia, Point, 51017, Italy
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Pavia, PV, 27100, Italy
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Ariccia, RM, 00041, Italy
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Roma, RM, 00163, Italy
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Salerno, SA, 84131, Italy
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Sassari, SS, 07100, Italy
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Daugavpils, LV-5417, Latvia
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Kaunas, LT-49387, Lithuania
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Kėdainiai, LT-57164, Lithuania
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Kuala Lumpur, 50400, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Aguascalientes, 20230, Mexico
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Breda, CK, 4818, Netherlands
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Amersfoort, 3813 TZ, Netherlands
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Arnhem, 6815 AD, Netherlands
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Blaricum, 1261 AN, Netherlands
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Ede, 6716 RP, Netherlands
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Gorinchem, 4204 AA, Netherlands
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Hardenberg, 7770 AA, Netherlands
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Heerenveen, 8441 PW, Netherlands
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Hengelo, 7555 DL, Netherlands
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Sneek, 8601 ZK, Netherlands
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Veldhoven, 5504 DB, Netherlands
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San Borja, Lima region, 41, Peru
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San Miguel, Lima region, 32, Peru
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Ivanovo, 153012, Russia
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Krasnodar, 350012, Russia
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Saint Petersburg, 197341, Russia
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Saint Petersburg, 199106, Russia
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Saratov, 410012, Russia
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Smolensk, 214018, Russia
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Tula, 300053, Russia
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Vladimir, 600020, Russia
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Yekaterinburg, 620137, Russia
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Brezno, Slovak Republic, 977 42, Slovakia
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Košice, Slovak Republic, 040 22, Slovakia
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Levice, Slovak Republic, 93401, Slovakia
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Prešov, Slovak Republic, 08001, Slovakia
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Svidník, Slovak Republic, 08901, Slovakia
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Bratislava, 821 07, Slovakia
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Bratislava, 842 31, Slovakia
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Bratislava, 851 07, Slovakia
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Košice, 040 01, Slovakia
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Lučenec, 984 01, Slovakia
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Martin, 036 01, Slovakia
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Bloemfontein, Free State, 9301, South Africa
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Soweto, Gauteng, 2013, South Africa
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Durban, KwaZulu-Natal, 4052, South Africa
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Alberton, 1449, South Africa
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Bloemfontein, 9301, South Africa
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Durban, 4110, South Africa
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Johannesburg, 2193, South Africa
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Worcester, 6850, South Africa
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Wŏnju, Gangwon-do, 26426, South Korea
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Daegu, 705 718, South Korea
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Daegu, 705703, South Korea
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Seoul, 05355, South Korea
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Seoul, 156-707, South Korea
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Marbella, Andalusia, 29600, Spain
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Móstoles, Madrid, 28935, Spain
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Valencia, Valencia, 46010, Spain
Novartis Investigative Site
Valencia, Valencia, 46015, Spain
Novartis Investigative Site
Madrid, 28007, Spain
Novartis Investigative Site
Madrid, 28222, Spain
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Stockholm, SE, 141 86, Sweden
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Gothenburg, 416 85, Sweden
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Karlshamn, 37480, Sweden
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Motala, 59185, Sweden
Novartis Investigative Site
Changhua, 50006, Taiwan
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Kaohsiung City, 82445, Taiwan
Novartis Investigative Site
Taichung, 40447, Taiwan
Novartis Investigative Site
Taipei, 10002, Taiwan
Novartis Investigative Site
Taipei, 11217, Taiwan
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Taipei, 114, Taiwan
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Yilan, 26058, Taiwan
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Taladkwan, Changwat Nonthaburi, 11000, Thailand
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Muang, Thailand, 12120, Thailand
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Khon Kaen, THA, 40002, Thailand
Novartis Investigative Site
Istanbul, 34093, Turkey (Türkiye)
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Istanbul, 34304, Turkey (Türkiye)
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Izmir, 35040, Turkey (Türkiye)
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Izmir, 35340, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Sivas, 58140, Turkey (Türkiye)
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Durham, County Durham, DH1 5TW, United Kingdom
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Dorchester, Dorset, DT1 2JY, United Kingdom
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Basingstoke, Hampshire, RG24 9NA, United Kingdom
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Portsmouth, Hampshire, PO6 3LY, United Kingdom
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Inverness, Invernesshire, IV2 3RE, United Kingdom
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Oldham, Lancashire, OL1 2JH, United Kingdom
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Leicester, Leicestershire, LE2 7LX, United Kingdom
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Craigavon, Northern Ireland, BT63 5QQ, United Kingdom
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Dundee, Perthshire, DD1 9SY, United Kingdom
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Taunton, Somerset, TA1 5DA, United Kingdom
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Yeovil, Somerset, BA21 4AT, United Kingdom
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Sheffield, South Yorkshire, S10 2JF, United Kingdom
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Redhill, Surrey, RH1 5RH, United Kingdom
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South Shields, Tyne and Wear, NE34 0PL, United Kingdom
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Sunderland, Tyne and Wear, SR4 7TP, United Kingdom
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Dudley, West Midlands, DY1 2HQ, United Kingdom
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Cheshire, CW1 4QJ, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Exeter, EX2 5AX, United Kingdom
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Kent, DA2 8DA, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Milton Keynes, MK6 5LD, United Kingdom
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Newport, NP20 2UB, United Kingdom
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Newport, P030 5TG, United Kingdom
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Norwich, NR4 7UY, United Kingdom
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Poole, BH15 2JB, United Kingdom
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Rotherham, S60 2OD, United Kingdom
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Worcester, WR5 1DD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Two patients had missing treatment epoch disposition pages but were included in Safety Analysis Set (SAF)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2014
First Posted
August 27, 2014
Study Start
October 16, 2014
Primary Completion
December 28, 2017
Study Completion
December 28, 2017
Last Updated
February 20, 2019
Results First Posted
February 20, 2019
Record last verified: 2019-02