A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-WeekStudy to Evaluate the Efficacy and Safety ofEzetimibe/Simvastatin Versus Atorvastatin in Patients with MetabolicSyndrome and Hypercholesterolemia at High Risk for CoronaryHeart Disease
Phase 1
- Conditions
- HypercholesterolemiaMedDRA version: 8.1Level: LLTClassification code 10020604Term: Hypercholesterolemia
- Registration Number
- EUCTR2006-006497-17-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1120
Inclusion Criteria
Patient has a diagnosis of metabolic syndrome and hyperclosterolemia.
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 screening lab values/findings outside required ranges.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In high risk patients for CHD with metabolic syndrome and<br>hypercholesterolemia, to evaluate the LDL-C lowering efficacy of the ezetimibe/simvastatin combination tablet compared to atorvastatin.<br>;Secondary Objective: Evaluate the percentage of patients achieving a serum LDL-C<br><70 mg/dL (1.81 mmol/L) after 6 weeks of treatment.<br>;Primary end point(s): LDL cholesterol lowering
- Secondary Outcome Measures
Name Time Method