Randomised Olmesartan and Diabetes Microalbuminuria Prevention Study - Roadmap

Sankyo Pharma GmbH0 个研究点目标入组 4,400 人开始时间: 2005年1月21日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•-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).

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