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HypertensionPhase 4NCT00168857

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)

A Phase 4 study testing telmisartan and losartan in people with Hypertension and Diabetic Nephropathies, run by Boehringer Ingelheim at 109 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Hypertension, Diabetic Nephropathies
What is being tested?
telmisartan and losartan
How many people
860 participants
Where
109 sitesin 10 countries
Study dates
9 Jul 2003to 1 Jun 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
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  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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
  • Further exclusion criteria apply

Trial locations and contacts

109 sites in 10 countries.

109 sites in 10 countries

United States47 sites

  • Boehringer Ingelheim Investigational Site

    Atlanta, Georgia

  • Medical College of Georgia

    Augusta, Georgia

  • Boehringer Ingelheim Investigational Site

    Boston, Massachusetts

  • University of Vermont

    Burlington, Vermont

  • Medical University of South Carolina

    Charleston, South Carolina

  • University of Virginia Health Science Center

    Charlottesville, Virginia

  • Rush Presbyterian - St. Lukes Medical Center

    Chicago, Illinois

  • The Cleveland Foundation

    Cleveland, Ohio

  • The University of Texas Southwestern Medical Center

    Dallas, Texas

  • University of Colorado Health Sciences Center

    Denver, Colorado

  • Boehringer Ingelheim Investigational Site

    Des Moines, Iowa

  • Boehringer Ingelheim Investigational Site

    Eatontown, New Jersey

  • Boehringer Ingelheim Investigational Site

    Flushing, New York

  • Boehringer Ingelheim Investigational Site

    Gig Harbor, Washington

  • Boehringer Ingelheim Investigational Site

    Hollywood, Florida

  • Boehringer Ingelheim Investigational Site

    Lancaster, California

  • Boehringer Ingelheim Investigational Site

    Largo, Florida

  • Boehringer Ingelheim Investigational Site

    Little Rock, Arkansas

  • Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • VA of Greater Los Angeles

    Los Angeles, California

  • Clement J. Zablocki Veterans Administration Medical Center

    Milwaukee, Wisconsin

  • Winthrop University Hospital

    Mineola, New York

  • Boehringer Ingelheim Investigational Site

    Montgomery, Alabama

  • Louisiana State University Health Science Center

    New Orleans, Louisiana

  • Harlem Hospital

    New York, New York

  • University of Medicine and Dentistry of New Jersey

    Newark, New Jersey

  • Northport VAMC - Medical Service (111)

    Northport, New York

  • Boehringer Ingelheim Investigational Site

    Ocala, Florida

  • UCI Medical Center

    Orange, California

  • Boehringer Ingelheim Investigational Site

    Pembroke Pines, Florida

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania

  • Temple University Hospital

    Philadelphia, Pennsylvania

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania

  • Wake Nephrology Associates, PA

    Raleigh, North Carolina

  • Boehringer Ingelheim Investigational Site

    San Antonio, Texas

  • University of Texas Health and Science Center at San Antonio

    San Antonio, Texas

  • VA San Diego Healthcare System

    San Diego, California

  • Boehringer Ingelheim Investigational Site

    Santa Ana, California

  • Boehringer Ingelheim Investigational Site

    Seattle, Washington

  • Boehringer Ingelheim Investigational Site

    Shreveport, Louisiana

  • Boehringer Ingelheim Investigational Site

    Springfield, Massachusetts

  • UCLA Medical Center

    Sylmar, California

  • Boehringer Ingelheim Investigational Site

    Tampa, Florida

  • Torrance Clinical Research

    Torrance, California

  • Boehringer Ingelheim Investigational Site

    Towson, Maryland

  • George Washington University

    Washington D.C., District of Columbia

  • Boehringer Ingelheim Investigational Site

    Wheat Ridge, Colorado

Other trials in United States

Canada22 sites

  • Boehringer Ingelheim Investigational Site

    Calgary, Alberta

  • Division of Respirology

    Halifax, Nova Scotia

  • Boehringer Ingelheim Investigational Site

    Kitchener, Ontario

  • Boehringer Ingelheim Investigational Site

    Laval, Quebec

  • Boehringer Ingelheim Investigational Site

    London, Ontario

  • Credit Valley Hospital

    Mississauga, Ontario

  • CHUM - Hote-Dieu

    Montreal, Quebec

  • Hopital Maisonneuve Rosemont

    Montreal, Quebec

  • Boehringer Ingelheim Investigational Site

    Oakville, Ontario

  • The Ottawa Hospital - Riverside Campus

    Ottawa, Ontario

  • Boehringer Ingelheim Investigational Site

    Red Deer, Alberta

  • Boehringer Ingelheim Investigational Site

    Saskatoon, Saskatchewan

  • CHUS - Hopital Fleurimont

    Sherbrooke, Quebec

  • LIfestyle Metabolism Centre - Thornhill

    Thornhill, Ontario

  • Boehringer Ingelheim Investigational Site

    Timmins, Ontario

  • Boehringer Ingelheim Investigational Site

    Toronto, Ontario

  • St. Michael's Hospital

    Toronto, Ontario

  • Sunnybrook & Woman's College Health Science Centre

    Toronto, Ontario

  • BC Endocrine Research Foundation

    Vancouver, British Columbia

  • Endocrine Research Society

    Vancouver, British Columbia

  • Humber River Regional Hospital, Dialysis Unit

    Weston, Ontario

  • University of Manitoba, Diabetes Research Group

    Winnipeg, Manitoba

Other trials in Canada

Argentina8 sites

  • Boehringer Ingelheim Investigational Site

    Buenos Aires

  • Boehringer Ingelheim Investigational Site

    Córdoba

  • Clinica Coronel Suarez

    Coronel Suárez

  • Boehringer Ingelheim Investigational Site

    Paraná

  • Boehringer Ingelheim Investigational Site

    Provincia de Buenos Aires

  • Boehringer Ingelheim Investigational Site

    Rosario, Santa Fé

  • Hospital San Bernardo

    Salta

  • Boehringer Ingelheim Investigational Site

    Santa Fe

Other trials in Argentina

Mexico7 sites

  • Fracc. Magallanes

    Acapulco Guerrero

  • Boehringer Ingelheim Investigational Site

    Col. Sección XVI, Deleg. Tlalpan

  • Cardiology

    Guadalajara

  • Hospital Civil Nuevo de Guadalajara

    Guadalajara

  • Boehringer Ingelheim Investigational Site

    Guadalajara, Jalisco

  • Dep of Neurology

    Metepec

  • Cardiologia

    México, D.F.

Other trials in Mexico

Taiwan6 sites

  • Buddhist Tzu Chi General Hospital

    Chiayi City

  • Buddhist Tzu Chi General Hospital

    Hualien City

  • Chi Mei Medical Center

    Tainan

  • Cathay General Hospital

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

Thailand6 sites

  • Bumrungrad Hospital

    Bangkok

  • Pramongkutklao Hospital

    Bangkok

  • Siriraj Hospital, Division of Hypertension

    Bangkok

  • Thummasart University Hospital

    Bangkok

  • Maharaj Nakom Chiang Mai Hospital

    Chiang Mai

  • Srinagarind Hospital

    Khon Kaen

Other trials in Thailand

Australia4 sites

  • Lyell McEwin Hospital Department of medicine

    Elizabeth, South Australia

  • Geelong Clinical Research Centre

    Geelong, Victoria

  • Boehringer Ingelheim Investigational Site

    Kippa-Ring, Queensland

  • Boehringer Ingelheim Investigational Site

    Melbourne, Victoria

Other trials in Australia

Brazil4 sites

  • Universidade Federal do Pará

    Belém

  • Boehringer Ingelheim Investigational Site

    Botucatu

  • Faculdade de Medicina Universidade Federal de Juiz de Fora

    Juiz de Fora ¿ MG

  • Boehringer Ingelheim Investigational Site

    Vila Clementino, São Paulo

Other trials in Brazil

South Korea3 sites

  • Dongsan Medical Center

    Daegu

  • National Health Insurance Corporation, Ilsan Hospital

    Gyunggido

  • Yongdong Severance Hospital

    Seoul

Other trials in South Korea

New Zealand2 sites

  • Boehringer Ingelheim Investigational Site

    Auckland

  • 1st Floor Hagely Hostel

    Christchurch

Other trials in New Zealand

About this 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)

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).

Being tested
telmisartan, losartan
Medical subject headings
Hypertension, Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telmisartanDrug

  • losartanDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 1 year

Secondary outcomes (1)

  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.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study start9 Jul 2003
  3. Primary completion1 Jun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
860 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00168857
Sponsor's protocol ID
502.397
Status last verified
Nov 2023
First submitted
9 Sep 2005
Last updated
8 Dec 2023
Results posted
No

Publications

  • 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.

    PubMed 38682786

  • 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.

    PubMed 18496508

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing telmisartan and losartan in people with Hypertension and Diabetic Nephropathies, run by Boehringer Ingelheim at 109 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, Canada, Argentina, Mexico, Taiwan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample). (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00168857, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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