Status:
COMPLETED
Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Metabolic Syndrome
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.
Eligibility Criteria
Inclusion
- Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category
Exclusion
- A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
- Patient is likely to be greater than 20% noncompliant in taking study medications
- Patients with chronic medical conditions
- Patients with unstable doses of medications
- Pregnant or lactating women, women intending to become pregnant
- Patient is currently receiving prescription therapy with statins or other lipid-altering medications
- Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
1143 Patients enrolled
Trial Details
Trial ID
NCT00409773
Start Date
January 1 2007
End Date
July 1 2008
Last Update
May 16 2024
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