A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin (10mg/20mg) compared to Rosuvastatin 10mg in patients with primary hypercholesterolemia and high cardiovascular risk and not adequately controlled with a prior statin treatment. (IN-CROSS). - Study to Assess the LDL-C Lowering of Switching to a Combination Tablet, Ezetimibe/Simvastatin (10mg
Phase 1
- Conditions
- HypercholesterolimiaMedDRA version: 8.1 Level: HLT Classification code 10014476 Term: Elevated cholesterol
- Registration Number
- EUCTR2006-005513-35-CZ
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 56
Inclusion Criteria
LDL-C level = 100 mg/dL (2.50 mmol/L) and = 190 mg/dl (4.9 mmol/L) (sample collected at visit 1)
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 liver or kidney disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In patients with primary hypercholesterolemia and high cardiovascular risk treated with a statin and with elevated LDL-Cholesterol at baseline to assess the additional LDL-C percentage reduction by switching to ezetimibe/simvastatin compared to rosuvastatin.;<br> Secondary Objective: 1 to determine the percentage of patients reaching LDL-C <100 mg/dL (2.5 mmol/L) with ezetimibe/simvastatin (10mg/20mg) compared to rosuvastatin 10 mg<br> 2 to determine the percentage of patients reaching LDL-C < 70 mg/dL (1.8 mmol/L) with ezetimibe/simvastatin (10mg/20mg) compared to rosuvastatin 10 mg<br> ;Primary end point(s): LDL cholesterol lowering
- Secondary Outcome Measures
Name Time Method