A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patient with Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease - ND
Phase 1
Active, not recruiting
- Conditions
- metabolic syndrome and hypercholesterolemiaMedDRA version: 6.1 Level: SOC Classification code 10007541
- Registration Number
- EUCTR2006-006497-17-IT
- Lead Sponsor
- MERCK SHARP DOHME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 1120
Inclusion Criteria
Patient has a diagnosis of metabolic syndrome and hypercholesterolemia
Are the trial subjects under 18? yes
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 patients at high risk for CHD, with metabolic syndrome and hypercholesterolemia, to evaluate the LDL-C lowering efficacy of the ezetimibe/simvastatin combination tablet compared to atorvastatin.;Secondary Objective: Evaluate the percentage of patients achieving a serum LDL-C < 70 mg/dL (1.81 mmol/L) after 6 weeks of treatment;Primary end point(s): LDL cholesterol lowering
- Secondary Outcome Measures
Name Time Method