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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2004-000506-52-EE |
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Date of registration:
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26/11/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomised Olmesartan and Diabetes Microalbuminuria prevention study - ROADMAP
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Scientific title:
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Randomised Olmesartan and Diabetes Microalbuminuria prevention study - ROADMAP |
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Date of first enrolment:
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01/11/2004 |
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Target sample size:
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4400 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000506-52 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind: yes
Parallel group: yes
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo: yes
Other:
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Phase:
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Countries of recruitment
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Czech Republic
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Estonia
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Hungary
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Italy
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Latvia
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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NIDDM (non insulin dependent diabetes mellitus)
Classification code 10029402
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Intervention(s)
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Trade Name: Mesar /Olmetec
Product Name: Mesar, Olemetc
Product Code: NA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: olmesartan medoximil
Current Sponsor code: CS-866
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40mg, 20mg, 10mg-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s):
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Secondary Objective: To test the hypothesis that treatment with olmesartan medoximil has a positive effect on cardiovascular and renal morbidity and mortality.
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Main Objective: To determine the difference in the time to event of microalbuminuria in patients receiving 40 mg olmesartan medoximil compared to placebo using morning spot urine collections, assessed from baseline until occurrence of microalbuminuria
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Secondary ID(s)
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2004-000506-52-CZ
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SE-866/44
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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