Randomised Olmesartan and Diabetes Microalbuminuria Prevention Study - ROADMAP

• Conditions: IDDM (non insulin dependent diabetes mellitus); MedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2004-000506-52-GB
• Lead Sponsor: Daiichi Sankyo Europe GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

- Male or female Caucasian patients with Type II diabetes mellitus aged between 18 and 75 years 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 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)
-Hypertension: sBP > or = 130 mmHg and/or dBP > or = 80 mmHg
-Obesity: BMI > or = 28 kg/sq.m
-Waist circumference: > 102 cm for men, >88 cm for women
-Smoking: more than 5 cigarettes a day
- Patients with fasting blood glucose > or = 126 mg/dL (7 mmol/L) (only for patients not receiving treatment for diabetes)
- Patients with HbA1c > or = 6.5 % (only for patients not receiving treatment for diabetes)
- Patients with normoalbuminuria at screening: < or = 35 mg albumin/g urine creatinine for women and < or = 25 mg albumin /g urine creatinine for men

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 documented renal and/or renal vascular disease
- Patients with myocardial infarction, stroke, transient ischaemic attack or myocardial revascularisation or reperfusion within the last 6 months
- Patients with ASAT and ALAT greater than twice the upper limit of the laboratory reference range. Patients with GGT greater than twice the upper limit will only be excluded if ASAT or ALAT are greater than 1.5 times the upper limits
- Patients with known allergic reaction, lack of response or contraindication to ARBs
- Patients with severe hypertension (sBP > 200 mmHg and/or dBP > 110 mmHg)
- Patients with severe heart failure: NYHA Stage 3-4
- Patients with a history of drug abuse or within the last two years, alcohol addiction
- Patients receiving ARBs or ACE inhibitors within the last 6 months
- Patients with severe hyperlipidaemia
- Patients requiring psychoactive drugs (except anti-anxiety drugs, anti-depressants and medications used for the treatment of sleeping disorders). Selective serotonin reuptake inhibitors (SSRIs) are not allowed

Study & Design

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