A Randomized, Double-Blind, Active-Controlled, MulticenterStudy of Patients with Primary Hypercholesterolemia and HighCardiovascular Risk and not Adequately Controlled with Atorvastatin20 mg: A Comparison of Switching to a Combination TabletEzetimibe/Simvastatin (10mg/40mg) versus Doubling the BaselineDose to Atorvastatin 40 mg
- Conditions
- primary hypercholesterolemiaMedDRA version: 9.1Level: LLTClassification code 10020604Term: Hypercholesterolemia
- Registration Number
- EUCTR2008-005002-40-LV
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
ATP II High Risk patients >=18 and <80 years of age with primary hypercholesterolemia, either statin/ezetimibe naïve or on an acceptable stable dose, and willing to maintain a cholesterol-lowering diet for the duration of the study. Baseline LDL-C must be between = 100 mg/dL (2.59 mmol/L) and = 160 mg/dL (4.14 mmol/L), TG = 350 mg/dL (3.96 mmol/L), ALT/AST = 2.0 X ULN, and CK = 3.0 X ULN.
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
Patient is hypersensitive/intolerant to any component of the study medication, has CHF NYHA Class III or IV, is an uncontrolled hypertensive or diabetic, or is actively trying to lose weight. Prohibited medications include CYP3A4 inhibitors, lipid-lowering agents, systemic corticosteroids, anti-obesity medications, warfarin, or medications that could increase the risk of myopathy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method