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)
- Conditions
- HypertensionDiabetic Nephropathies
- Registration Number
- NCT00168857
- Lead Sponsor
- Boehringer Ingelheim
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 860
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (65)
Fracc. Magallanes
🇲🇽Acapulco Guerrero, Mexico
VA Pittsburgh Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
Pramongkutklao Hospital
🇹🇭Bangkok, Thailand
Rush Presbyterian - St. Lukes Medical Center
🇺🇸Chicago, Illinois, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
UCLA Medical Center
🇺🇸Sylmar, California, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Harlem Hospital
🇺🇸New York, New York, United States
Boehringer Ingelheim Investigational Site
🇳🇿Auckland, New Zealand
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The Ottawa Hospital - Riverside Campus
🇨🇦Ottawa, Ontario, Canada
Lyell McEwin Hospital Department of medicine
🇦🇺Elizabeth, South Australia, Australia
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Wake Nephrology Associates, PA
🇺🇸Raleigh, North Carolina, United States
Northport VAMC - Medical Service (111)
🇺🇸Northport, New York, United States
Universidade Federal do Pará
🇧🇷Belém, Brazil
University of Virginia Health Science Center
🇺🇸Charlottesville, Virginia, United States
LIfestyle Metabolism Centre - Thornhill
🇨🇦Thornhill, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
University of Vermont
🇺🇸Burlington, Vermont, United States
National Health Insurance Corporation, Ilsan Hospital
🇰🇷Gyunggido, Korea, Republic of
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
The Cleveland Foundation
🇺🇸Cleveland, Ohio, United States
University of Texas Health and Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
CHUS - Hopital Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Yongdong Severance Hospital
🇰🇷Seoul, Korea, Republic of
Cardiology
🇲🇽Guadalajara, Mexico
Dep of Neurology
🇲🇽Metepec, Mexico
UCI Medical Center
🇺🇸Orange, California, United States
VA of Greater Los Angeles
🇺🇸Los Angeles, California, United States
Torrance Clinical Research
🇺🇸Torrance, California, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
Clinica Coronel Suarez
🇦🇷Coronel Suarez, Argentina
Faculdade de Medicina Universidade Federal de Juiz de Fora
🇧🇷Juiz De Fora ¿ MG, Brazil
University of Manitoba, Diabetes Research Group
🇨🇦Winnipeg, Manitoba, Canada
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Humber River Regional Hospital, Dialysis Unit
🇨🇦Weston, Ontario, Canada
Cardiologia
🇲🇽México, D.F., Mexico
1st Floor Hagely Hostel
🇳🇿Christchurch, New Zealand
Buddhist Tzu Chi General Hospital
🇨🇳Hualien, Taiwan
Cathay General Hospital
🇨🇳Taipei, Taiwan
Chi Mei Medical Center
🇨🇳Tainan, Taiwan
Bumrungrad Hospital
🇹🇭Bangkok, Thailand
Siriraj Hospital, Division of Hypertension
🇹🇭Bangkok, Thailand
Thummasart University Hospital
🇹🇭Bangkok, Thailand
Maharaj Nakom Chiang Mai Hospital
🇹🇭Chiang Mai, Thailand
Sunnybrook & Woman's College Health Science Centre
🇨🇦Toronto, Ontario, Canada
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Clement J. Zablocki Veterans Administration Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Division of Respirology
🇨🇦Halifax, Nova Scotia, Canada
Hospital San Bernardo
🇦🇷Salta, Argentina
George Washington University
🇺🇸Washington, District of Columbia, United States
The University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
CHUM - Hote-Dieu
🇨🇦Montreal, Quebec, Canada
Srinagarind Hospital
🇹🇭Khon Kaen, Thailand
Louisiana State University Health Science Center
🇺🇸New Orleans, Louisiana, United States
Hopital Maisonneuve Rosemont
🇨🇦Montreal, Quebec, Canada
Hospital Civil Nuevo de Guadalajara
🇲🇽Guadalajara, Mexico
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Geelong Clinical Research Centre
🇦🇺Geelong, Victoria, Australia
BC Endocrine Research Foundation
🇨🇦Vancouver, British Columbia, Canada
Endocrine Research Society
🇨🇦Vancouver, British Columbia, Canada