Olmesartan Medoxomil in Diabetes Mellitus

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sankyo Pharma Gmbh
• Treatments: Olmesartan; Olmesartan Medoxomil

Criteria

Inclusion Criteria:

• Diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL;

• Presence of at least one of the following cardiovascular risk factors:

1. total cholesterol greater than 200 mg/dL or statin treatment,

2. High density lipoprotein (HDL) less than 40 mg/dL,

3. triglycerides greater than 150 mg/dL and less than 400 mg/dL,

4. blood pressure greater than or equal to 130/80 mmHg,

5. Body mass index (BMI) greater than 28 kg/m2,

6. waist circumference greater than 102 cm for men and greater than 88 cm for women,

7. smoking of more than 5 cigarettes a day;

• Normoalbuminuria at screening

Exclusion Criteria:

• Severe uncontrolled hyperlipidemia;

• Documented renal and/or renal-vascular disease;

• Myocardial infarction, stroke or myocardial revascularization within the last 6 months;

• History of alcohol and/or drug abuse;

• Allergic reaction, lack of response or contraindication to angiotensin receptor blockers (ARBs);

• Current treatment with an ARB or angiotensin converting enzyme (ACE) inhibitor