Randomised Olmesartan and Diabetes Microalbuminuria Prevention Study - Roadmap

• Conditions: IDDM (no insulin dependent diabetes mellitus); Classification code 10029402

• Registration Number: EUCTR2004-000506-52-LV
• Lead Sponsor: Sankyo Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4400

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified