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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Vermont
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos aIRES
Country [25] 0 0
Argentina
State/province [25] 0 0
Coronel Suarez
Country [26] 0 0
Argentina
State/province [26] 0 0
Córdoba
Country [27] 0 0
Argentina
State/province [27] 0 0
Paraná
Country [28] 0 0
Argentina
State/province [28] 0 0
Provincia De Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Rosario, Santa Fé
Country [30] 0 0
Argentina
State/province [30] 0 0
Salta
Country [31] 0 0
Argentina
State/province [31] 0 0
Santa Fe
Country [32] 0 0
Brazil
State/province [32] 0 0
Belém
Country [33] 0 0
Brazil
State/province [33] 0 0
Botucatu
Country [34] 0 0
Brazil
State/province [34] 0 0
Juiz De Fora ¿ MG
Country [35] 0 0
Brazil
State/province [35] 0 0
Vila Clementino, São Paulo
Country [36] 0 0
Canada
State/province [36] 0 0
Alberta
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Manitoba
Country [39] 0 0
Canada
State/province [39] 0 0
Nova Scotia
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Canada
State/province [42] 0 0
Saskatchewan
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Daegu
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Gyunggido
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Seoul
Country [46] 0 0
Mexico
State/province [46] 0 0
Acapulco Guerrero
Country [47] 0 0
Mexico
State/province [47] 0 0
Col. Sección XVI, Deleg. Tlalpan
Country [48] 0 0
Mexico
State/province [48] 0 0
Guadalajara, Jalisco
Country [49] 0 0
Mexico
State/province [49] 0 0
Guadalajara
Country [50] 0 0
Mexico
State/province [50] 0 0
Metepec
Country [51] 0 0
Mexico
State/province [51] 0 0
México, D.F.
Country [52] 0 0
New Zealand
State/province [52] 0 0
Auckland
Country [53] 0 0
New Zealand
State/province [53] 0 0
Christchurch
Country [54] 0 0
Taiwan
State/province [54] 0 0
Chiayi
Country [55] 0 0
Taiwan
State/province [55] 0 0
Hualien
Country [56] 0 0
Taiwan
State/province [56] 0 0
Tainan
Country [57] 0 0
Taiwan
State/province [57] 0 0
Taipei
Country [58] 0 0
Thailand
State/province [58] 0 0
Bangkok
Country [59] 0 0
Thailand
State/province [59] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00168857