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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)

Primary Purpose

Hypertension, Diabetic Nephropathies

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
telmisartan
losartan
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • VA of Greater Los Angeles
  • UCI Medical Center
  • VA San Diego Healthcare System
  • Boehringer Ingelheim Investigational Site
  • UCLA Medical Center
  • Torrance Clinical Research
  • University of Colorado Health Sciences Center
  • Boehringer Ingelheim Investigational Site
  • George Washington University
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Medical College of Georgia
  • Rush Presbyterian - St. Lukes Medical Center
  • Boehringer Ingelheim Investigational Site
  • Louisiana State University Health Science Center
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • University of Medicine and Dentistry of New Jersey
  • Boehringer Ingelheim Investigational Site
  • Winthrop University Hospital
  • Harlem Hospital
  • Northport VAMC - Medical Service (111)
  • Wake Nephrology Associates, PA
  • The Cleveland Foundation
  • Hospital of the University of Pennsylvania
  • Temple University Hospital
  • VA Pittsburgh Healthcare System
  • Medical University of South Carolina
  • The University of Texas Southwestern Medical Center
  • Boehringer Ingelheim Investigational Site
  • University of Texas Health and Science Center at San Antonio
  • University of Vermont
  • University of Virginia Health Science Center
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Clement J. Zablocki Veterans Administration Medical Center
  • Boehringer Ingelheim Investigational Site
  • Clinica Coronel Suarez
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Hospital San Bernardo
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Lyell McEwin Hospital Department of medicine
  • Geelong Clinical Research Centre
  • Boehringer Ingelheim Investigational Site
  • Universidade Federal do Pará
  • Boehringer Ingelheim Investigational Site
  • Faculdade de Medicina Universidade Federal de Juiz de Fora
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • BC Endocrine Research Foundation
  • Endocrine Research Society
  • University of Manitoba, Diabetes Research Group
  • Division of Respirology
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Credit Valley Hospital
  • Boehringer Ingelheim Investigational Site
  • The Ottawa Hospital - Riverside Campus
  • LIfestyle Metabolism Centre - Thornhill
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • St. Michael's Hospital
  • Sunnybrook & Woman's College Health Science Centre
  • Humber River Regional Hospital, Dialysis Unit
  • Boehringer Ingelheim Investigational Site
  • CHUM - Hote-Dieu
  • Hopital Maisonneuve Rosemont
  • CHUS - Hopital Fleurimont
  • Boehringer Ingelheim Investigational Site
  • Dongsan Medical Center
  • National Health Insurance Corporation, Ilsan Hospital
  • Yongdong Severance Hospital
  • Fracc. Magallanes
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Cardiology
  • Hospital Civil Nuevo de Guadalajara
  • Dep of Neurology
  • Cardiologia
  • Boehringer Ingelheim Investigational Site
  • 1st Floor Hagely Hostel
  • Buddhist Tzu Chi General Hospital
  • Buddhist Tzu Chi General Hospital
  • Chi Mei Medical Center
  • Cathay General Hospital
  • National Taiwan University Hospital
  • Tri-Service General Hospital
  • Bumrungrad Hospital
  • Pramongkutklao Hospital
  • Siriraj Hospital, Division of Hypertension
  • Thummasart University Hospital
  • Maharaj Nakom Chiang Mai Hospital
  • Srinagarind Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 9, 2005
Last Updated
November 4, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00168857
Brief Title
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)
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetic Nephropathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
860 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
telmisartan
Intervention Type
Drug
Intervention Name(s)
losartan
Primary Outcome Measure Information:
Title
Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample).
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Montgomery
State/Province
Alabama
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Lancaster
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
VA of Greater Los Angeles
City
Los Angeles
State/Province
California
Country
United States
Facility Name
UCI Medical Center
City
Orange
State/Province
California
Country
United States
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Santa Ana
State/Province
California
Country
United States
Facility Name
UCLA Medical Center
City
Sylmar
State/Province
California
Country
United States
Facility Name
Torrance Clinical Research
City
Torrance
State/Province
California
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Wheatridge
State/Province
Colorado
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Largo
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Rush Presbyterian - St. Lukes Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Demoine
State/Province
Iowa
Country
United States
Facility Name
Louisiana State University Health Science Center
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Towson
State/Province
Maryland
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Eatontown
State/Province
New Jersey
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Flushing
State/Province
New York
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
Country
United States
Facility Name
Harlem Hospital
City
New York
State/Province
New York
Country
United States
Facility Name
Northport VAMC - Medical Service (111)
City
Northport
State/Province
New York
Country
United States
Facility Name
Wake Nephrology Associates, PA
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
The Cleveland Foundation
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
University of Texas Health and Science Center at San Antonio
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
University of Virginia Health Science Center
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Gig Harbor
State/Province
Washington
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Clement J. Zablocki Veterans Administration Medical Center
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Buenos aIRES
Country
Argentina
Facility Name
Clinica Coronel Suarez
City
Coronel Suarez
Country
Argentina
Facility Name
Boehringer Ingelheim Investigational Site
City
Córdoba
Country
Argentina
Facility Name
Boehringer Ingelheim Investigational Site
City
Paraná
Country
Argentina
Facility Name
Boehringer Ingelheim Investigational Site
City
Provincia de Buenos Aires
Country
Argentina
Facility Name
Boehringer Ingelheim Investigational Site
City
Rosario, Santa Fé
Country
Argentina
Facility Name
Hospital San Bernardo
City
Salta
Country
Argentina
Facility Name
Boehringer Ingelheim Investigational Site
City
Santa Fe
Country
Argentina
Facility Name
Boehringer Ingelheim Investigational Site
City
Kippa-Ring
State/Province
Queensland
Country
Australia
Facility Name
Lyell McEwin Hospital Department of medicine
City
Elizabeth
State/Province
South Australia
Country
Australia
Facility Name
Geelong Clinical Research Centre
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
Boehringer Ingelheim Investigational Site
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Universidade Federal do Pará
City
Belém
Country
Brazil
Facility Name
Boehringer Ingelheim Investigational Site
City
Botucatu
Country
Brazil
Facility Name
Faculdade de Medicina Universidade Federal de Juiz de Fora
City
Juiz de Fora ¿ MG
Country
Brazil
Facility Name
Boehringer Ingelheim Investigational Site
City
Vila Clementino, São Paulo
Country
Brazil
Facility Name
Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Red Deer
State/Province
Alberta
Country
Canada
Facility Name
BC Endocrine Research Foundation
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Endocrine Research Society
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
University of Manitoba, Diabetes Research Group
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Division of Respirology
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Credit Valley Hospital
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital - Riverside Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
LIfestyle Metabolism Centre - Thornhill
City
Thornhill
State/Province
Ontario
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Timmins
State/Province
Ontario
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook & Woman's College Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Humber River Regional Hospital, Dialysis Unit
City
Weston
State/Province
Ontario
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
CHUM - Hote-Dieu
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hopital Maisonneuve Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
CHUS - Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
National Health Insurance Corporation, Ilsan Hospital
City
Gyunggido
Country
Korea, Republic of
Facility Name
Yongdong Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Fracc. Magallanes
City
Acapulco Guerrero
Country
Mexico
Facility Name
Boehringer Ingelheim Investigational Site
City
Col. Sección XVI, Deleg. Tlalpan
Country
Mexico
Facility Name
Boehringer Ingelheim Investigational Site
City
Guadalajara, Jalisco
Country
Mexico
Facility Name
Cardiology
City
Guadalajara
Country
Mexico
Facility Name
Hospital Civil Nuevo de Guadalajara
City
Guadalajara
Country
Mexico
Facility Name
Dep of Neurology
City
Metepec
Country
Mexico
Facility Name
Cardiologia
City
México, D.F.
Country
Mexico
Facility Name
Boehringer Ingelheim Investigational Site
City
Auckland
Country
New Zealand
Facility Name
1st Floor Hagely Hostel
City
Christchurch
Country
New Zealand
Facility Name
Buddhist Tzu Chi General Hospital
City
Chiayi
Country
Taiwan
Facility Name
Buddhist Tzu Chi General Hospital
City
Hualien
Country
Taiwan
Facility Name
Chi Mei Medical Center
City
Tainan
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
Bumrungrad Hospital
City
Bangkok
Country
Thailand
Facility Name
Pramongkutklao Hospital
City
Bangkok
Country
Thailand
Facility Name
Siriraj Hospital, Division of Hypertension
City
Bangkok
Country
Thailand
Facility Name
Thummasart University Hospital
City
Bangkok
Country
Thailand
Facility Name
Maharaj Nakom Chiang Mai Hospital
City
Chiang Mai
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
18496508
Citation
Bakris 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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.397_U07-3079.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.397_literature.pdf
Description
Related Info

Learn more about this trial

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)

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