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)

Condition(s) targeted: Hypertension; Diabetic Nephropathies

Intervention: telmisartan (Drug); losartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim

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).

Official title: A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare MICARDIS® (Telmisartan) 80 mg Versus COZAAR® (Losartan) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample).

Secondary outcome: 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.

Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.

Boehringer Ingelheim Investigational Site, Buenos aIRES, Argentina

Clinica Coronel Suarez, Coronel Suarez, 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

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

Dongsan Medical Center, Daegu, Korea, Republic of

National Health Insurance Corporation, Ilsan Hospital, Gyunggido, Korea, Republic of

Yongdong Severance Hospital, Seoul, Korea, Republic of

Fracc. Magallanes, Acapulco Guerrero, Mexico

Boehringer Ingelheim Investigational Site, Col. Sección XVI, Deleg. Tlalpan, Mexico

Boehringer Ingelheim Investigational Site, Guadalajara, Jalisco, Mexico

Cardiology, Guadalajara, Mexico

Hospital Civil Nuevo de Guadalajara, Guadalajara, 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

Buddhist Tzu Chi General Hospital, Chiayi, Taiwan

Buddhist Tzu Chi General Hospital, Hualien, 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

Boehringer Ingelheim Investigational Site, Montgomery, Alabama, United States

Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada

Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada

Boehringer Ingelheim Investigational Site, Little Rock, Arkansas, United States

BC Endocrine Research Foundation, Vancouver, British Columbia, Canada

Endocrine Research Society, Vancouver, British Columbia, Canada

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, Wheatridge, Colorado, United States

George Washington University, Washington, 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, Demoine, Iowa, United States

Louisiana State University Health Science Center, New Orleans, Louisiana, United States

Boehringer Ingelheim Investigational Site, Shreveport, Louisiana, United States

University of Manitoba, Diabetes Research Group, Winnipeg, Manitoba, Canada

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

Division of Respirology, Halifax, Nova Scotia, Canada

The Cleveland Foundation, Cleveland, Ohio, United States

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

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

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, Kippa-Ring, Queensland, Australia

Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada

Lyell McEwin Hospital Department of medicine, Elizabeth, South Australia, Australia

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

Geelong Clinical Research Centre, Geelong, Victoria, Australia

Boehringer Ingelheim Investigational Site, Melbourne, Victoria, Australia

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

Starting date: July 2003
Last updated: November 4, 2013