A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)
1 other identifier
interventional
860
10 countries
109
Brief Summary
A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedDecember 8, 2023
November 1, 2023
2.9 years
September 9, 2005
December 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample).
Up to 1 year
Secondary Outcomes (1)
Change from baseline after one year of treatment in the following: glomerular filtration rate; serum creatinine; macroalbuminuria; sodium excretion; high sensitive C-reactive protein; serum aldosterone; and other renal and cardiovascular measures.
Up to 1 year
Interventions
Eligibility Criteria
You may qualify if:
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age 21-80 years
- Clinical history of type 2 diabetes mellitus, as defined by either:
- Hyperglycaemia not requiring insulin (diet, oral hypoglycaemic agents and metformin if patients serum creatinine levels were within normal limits.)
- Hyperglycaemia requiring insulin with: no history of diabetic ketoacidosis AND with either the period between diagnosis and insulin usage \>1 year or elevated fasting or stimulated C-peptide level
- Glycosylated haemoglobin A1 (HbA1c) ≤10%
- Diabetic nephropathy, as defined by:
- serum creatinine at Screening (Visit 1) ≤265 μmol/L (3.0 mg/dL) in women and ≤283 μmol/L (3.2 mg/dL) in men
- urinary protein/creatinine ratio ≥700 mg/g (measured in spot urine) during the run-in phase (Visit 2 or Visit 5 retest)
- Hypertension at screening, as defined by either:
- Mean systolic blood pressure (SBP) \>130 mmHg and/or mean diastolic blood pressure (DBP) \>80 mmHg in untreated patients
- Patients currently receiving antihypertensive medication (i.e. medications specifically prescribed to treat hypertension)
- Ability to stop current antihypertensive therapy with Angiotensin Converting Enzyme Inhibitor (ACE-Is), Angiotensin Receptor Blockers (ARBs) and direct vasodilators, and to stop chronic immunosuppressive therapy and current therapy with metformin without risk to the patient (Investigator's discretion).
- All female patients had to have negative results from the urine pregnancy test (UPT) at Visits 1 and 6 in order to be able to continue in the study.
You may not qualify if:
- Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:
- were not surgically sterile or
- were nursing or pregnant or
- were of child-bearing potential and were not practicing acceptable methods of birth control, or did not plan to continue practicing an acceptable method throughout the study (Note: Acceptable methods of birth control included transdermal patch, intra-uterine device, oral, implantable or injectable contraceptives) AND did not agree to periodic urine pregnancy testing (UPT) during participation in the study. No exceptions were made.
- Type 1 diabetes mellitus
- Increase of serum creatinine \>35% between Visit 1 (Screening) and Visit 5. If creatinine was increased \>35% at Visit 5, the measurement was to be repeated within five calendar days and if the increase was confirmed, the patient had to be excluded from the trial for safety reasons.
- Non-diabetic renal disease
- Congestive heart failure (New York Heart Association functional class III or IV)
- Unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous coronary intervention within the last three months prior to signing the informed consent form
- Stroke or transient ischaemic attack within the last six months prior to signing the informed consent form
- Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (109)
Boehringer Ingelheim Investigational Site
Montgomery, Alabama, United States
Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
Boehringer Ingelheim Investigational Site
Lancaster, California, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
VA of Greater Los Angeles
Los Angeles, California, United States
UCI Medical Center
Orange, California, United States
VA San Diego Healthcare System
San Diego, California, United States
Boehringer Ingelheim Investigational Site
Santa Ana, California, United States
UCLA Medical Center
Sylmar, California, United States
Torrance Clinical Research
Torrance, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
George Washington University
Washington D.C., District of Columbia, United States
Boehringer Ingelheim Investigational Site
Hollywood, Florida, United States
Boehringer Ingelheim Investigational Site
Largo, Florida, United States
Boehringer Ingelheim Investigational Site
Ocala, Florida, United States
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, United States
Boehringer Ingelheim Investigational Site
Des Moines, Iowa, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
Boehringer Ingelheim Investigational Site
Towson, Maryland, United States
Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
Boehringer Ingelheim Investigational Site
Eatontown, New Jersey, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States
Boehringer Ingelheim Investigational Site
Flushing, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Harlem Hospital
New York, New York, United States
Northport VAMC - Medical Service (111)
Northport, New York, United States
Wake Nephrology Associates, PA
Raleigh, North Carolina, United States
The Cleveland Foundation
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
University of Texas Health and Science Center at San Antonio
San Antonio, Texas, United States
University of Vermont
Burlington, Vermont, United States
University of Virginia Health Science Center
Charlottesville, Virginia, United States
Boehringer Ingelheim Investigational Site
Gig Harbor, Washington, United States
Boehringer Ingelheim Investigational Site
Seattle, Washington, United States
Clement J. Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, United States
Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina
Clinica Coronel Suarez
Coronel Suárez, Argentina
Boehringer Ingelheim Investigational Site
Córdoba, Argentina
Boehringer Ingelheim Investigational Site
Paraná, Argentina
Boehringer Ingelheim Investigational Site
Provincia de Buenos Aires, Argentina
Boehringer Ingelheim Investigational Site
Rosario, Santa Fé, Argentina
Hospital San Bernardo
Salta, Argentina
Boehringer Ingelheim Investigational Site
Santa Fe, Argentina
Boehringer Ingelheim Investigational Site
Kippa-Ring, Queensland, Australia
Lyell McEwin Hospital Department of medicine
Elizabeth, South Australia, Australia
Geelong Clinical Research Centre
Geelong, Victoria, Australia
Boehringer Ingelheim Investigational Site
Melbourne, Victoria, Australia
Universidade Federal do Pará
Belém, Brazil
Boehringer Ingelheim Investigational Site
Botucatu, Brazil
Faculdade de Medicina Universidade Federal de Juiz de Fora
Juiz de Fora ¿ MG, Brazil
Boehringer Ingelheim Investigational Site
Vila Clementino, São Paulo, Brazil
Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
Boehringer Ingelheim Investigational Site
Red Deer, Alberta, Canada
BC Endocrine Research Foundation
Vancouver, British Columbia, Canada
Endocrine Research Society
Vancouver, British Columbia, Canada
University of Manitoba, Diabetes Research Group
Winnipeg, Manitoba, Canada
Division of Respirology
Halifax, Nova Scotia, Canada
Boehringer Ingelheim Investigational Site
Kitchener, Ontario, Canada
Boehringer Ingelheim Investigational Site
London, Ontario, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
Boehringer Ingelheim Investigational Site
Oakville, Ontario, Canada
The Ottawa Hospital - Riverside Campus
Ottawa, Ontario, Canada
LIfestyle Metabolism Centre - Thornhill
Thornhill, Ontario, Canada
Boehringer Ingelheim Investigational Site
Timmins, Ontario, Canada
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook & Woman's College Health Science Centre
Toronto, Ontario, Canada
Humber River Regional Hospital, Dialysis Unit
Weston, Ontario, Canada
Boehringer Ingelheim Investigational Site
Laval, Quebec, Canada
CHUM - Hote-Dieu
Montreal, Quebec, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
CHUS - Hopital Fleurimont
Sherbrooke, Quebec, Canada
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Fracc. Magallanes
Acapulco Guerrero, Mexico
Boehringer Ingelheim Investigational Site
Col. Sección XVI, Deleg. Tlalpan, Mexico
Cardiology
Guadalajara, Mexico
Hospital Civil Nuevo de Guadalajara
Guadalajara, Mexico
Boehringer Ingelheim Investigational Site
Guadalajara, Jalisco, Mexico
Dep of Neurology
Metepec, Mexico
Cardiologia
México, D.F., Mexico
Boehringer Ingelheim Investigational Site
Auckland, New Zealand
1st Floor Hagely Hostel
Christchurch, New Zealand
Dongsan Medical Center
Daegu, South Korea
National Health Insurance Corporation, Ilsan Hospital
Gyunggido, South Korea
Yongdong Severance Hospital
Seoul, South Korea
Buddhist Tzu Chi General Hospital
Chiayi City, Taiwan
Buddhist Tzu Chi General Hospital
Hualien City, Taiwan
Chi Mei Medical Center
Tainan, Taiwan
Cathay General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Bumrungrad Hospital
Bangkok, Thailand
Pramongkutklao Hospital
Bangkok, Thailand
Siriraj Hospital, Division of Hypertension
Bangkok, Thailand
Thummasart University Hospital
Bangkok, Thailand
Maharaj Nakom Chiang Mai Hospital
Chiang Mai, Thailand
Srinagarind Hospital
Khon Kaen, Thailand
Related Publications (2)
Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
PMID: 38682786DERIVEDBakris G, Burgess E, Weir M, Davidai G, Koval S; AMADEO Study Investigators. Telmisartan is more effective than losartan in reducing proteinuria in patients with diabetic nephropathy. Kidney Int. 2008 Aug;74(3):364-9. doi: 10.1038/ki.2008.204. Epub 2008 May 21.
PMID: 18496508DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
July 9, 2003
Primary Completion
June 1, 2006
Last Updated
December 8, 2023
Record last verified: 2023-11