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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00168857




Registration number
NCT00168857
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
8/12/2023

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
502.397
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Diabetic Nephropathies 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - telmisartan
Treatment: Drugs - losartan

Treatment: Drugs: telmisartan


Treatment: Drugs: losartan
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample).
Timepoint [1] 0 0
Up to 1 year
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 1 year

Eligibility
Key inclusion criteria
Inclusion criteria:

- 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.
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- 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

- Further exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
860
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Boehringer Ingelheim Investigational Site - Kippa-Ring
Recruitment hospital [2] 0 0
Lyell McEwin Hospital Department of medicine - Elizabeth
Recruitment hospital [3] 0 0
Geelong Clinical Research Centre - Geelong
Recruitment hospital [4] 0 0
Boehringer Ingelheim Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Kippa-Ring
Recruitment postcode(s) [2] 0 0
- Elizabeth
Recruitment postcode(s) [3] 0 0
- Geelong
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Iowa
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Vermont
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Virginia
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos aIRES
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Argentina
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Coronel Suarez
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Argentina
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Córdoba
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Argentina
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Paraná
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Argentina
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Provincia De Buenos Aires
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Argentina
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Rosario, Santa Fé
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Argentina
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Salta
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Argentina
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Santa Fe
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Brazil
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Belém
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Brazil
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Botucatu
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Brazil
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Juiz De Fora ¿ MG
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Brazil
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Vila Clementino, São Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gyunggido
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Korea, Republic of
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Seoul
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Mexico
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Acapulco Guerrero
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Mexico
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Col. Sección XVI, Deleg. Tlalpan
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Mexico
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Guadalajara, Jalisco
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Mexico
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Guadalajara
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Mexico
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Metepec
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Mexico
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México, D.F.
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Taiwan
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Chiayi
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Taiwan
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Hualien
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Taiwan
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Tainan
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
Country [60] 0 0
Thailand
State/province [60] 0 0
Khon Kaen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00168857
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim Study Coordinator
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00168857