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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00168857
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
5/11/2013

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
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

Eligibility
Key inclusion criteria
Minimum age
21 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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/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
Other publications