Status:
COMPLETED
Olmesartan Medoxomil in Diabetes Mellitus
Lead Sponsor:
Sankyo Pharma Gmbh
Conditions:
Diabetes Mellitus, Type 2
Cardiovascular Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.
Eligibility Criteria
Inclusion
- 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:
- total cholesterol greater than 200 mg/dL or statin treatment,
- High density lipoprotein (HDL) less than 40 mg/dL,
- triglycerides greater than 150 mg/dL and less than 400 mg/dL,
- blood pressure greater than or equal to 130/80 mmHg,
- Body mass index (BMI) greater than 28 kg/m2,
- waist circumference greater than 102 cm for men and greater than 88 cm for women,
- smoking of more than 5 cigarettes a day;
- Normoalbuminuria at screening
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
4449 Patients enrolled
Trial Details
Trial ID
NCT00185159
Start Date
October 1 2004
End Date
July 1 2009
Last Update
January 20 2010
Active Locations (1)
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1
Darmstadt, Germany