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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. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2004-000506-52-LV |
Date of registration:
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21/01/2005 |
Prospective Registration:
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No |
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 |
Date of first enrolment:
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22/12/2004 |
Target sample size:
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4400 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000506-52 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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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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Key inclusion & exclusion criteria
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Inclusion criteria: male or female patients with type II diabetes mellitus defined by the American Diabetes Association (ADA) criteria (fasting blood glucose =126 mg/dL (7 mmol/L)) or receiving treatment for diabetes who have at least one of the following cardiovascular risk factors: - Lipid disorder defined as: total cholesterol > 200 mg/dL (5.2 mmol/L) or receiving treatment for hyperlipidaemia. - HDL < 40 mg/dL (1.1 mmol/L). - Triglycerides > 150 mg/dL (1.7 mmol/L) and < 400 mg/dL (4.5 mmol/L). - blood pressure: sBP =130 mmHg and/or dBP =80 mmHg. - obesity: BMI =28 m2/kg. - waist circumference: > 102 cm for men, >88 cm for women. - smoking: more than 5 cigarettes a day -normoalbuminuria at Screening less than or equal to 35 mg albumin/g urine creatinine for women and less than or equal to 25 mg albumin/g urine creatinine for men (confirmed by two independent measurements within two weeks).
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: - patients with severe hyperlipidaemia (high lipid values not controlled by usual treatment). - patients with documented renal and/or renal-vascular disease. - patients with myocardial infarction (MI), stroke or myocardial revascularization within the last 6 months. - patients with a history of drug abuse. - patients with alcohol addiction within the last two years. - patients with known allergic reaction, lack of response or contraindication to Ang II-antagonists. - patients receiving angiotensin receptor blocker (ARB) or angiotensin converting enzyme (ACE) inhibitor (within last 6 months).
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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NIDDM (no insulin dependent diabetes mellitus) Classification code 10029402
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Intervention(s)
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Trade Name: Olmetec 40mg Product Name: Olmetec Pharmaceutical Form: Film-coated tablet INN or Proposed INN: olmesartan medoxomil CAS Number: CS-866 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- 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): Time to the first occurrence of microalbuminuria defined as albumin excretion in morning urine (collected as spot urine) of > 35 mg albumin/g urine creatinine for women and > 25 mg albumin/g urine creatinine for men.
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Secondary Objective: To test the hypothesis that treatment with olmesartan medoxomil has a positive effect on cardiovascular and renal morbidity and mortality, as evaluated by: Cardiovascular mortality -sudden death and fatal MI -fatal stroke -combined endpoint Cardiovascular morbidity -coronary artery disease due to angina pectoris -myocardial insufficiency due to heart failure -transitory ischaemic attack, non-fatal myocardial infarction, non-fatal stroke -peripheral vascular disease -combined endpoint Renal disease -end-stage renal disease -worsening of renal function -combined endpoint Retinopathy -occurrence/progression of retinopathy -microvascular morbidity Analyse Subgroups -age and date of diagnosis and prognostic factors from beginning to end Safety and Tolerability -safety and tolerability of treatment
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Main Objective: To determine the difference in the time to event of microalbuminuria in patients receiving 40 mg olmesartan medoxomil 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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SE-866/44
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2004-000506-52-CZ
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Source(s) of Monetary Support
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Results
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