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).
Phase 1
- Conditions
- Adjunctive therapy to diet for the reduction of elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia.MedDRA version: 8.1 Level: HLT Classification code 10014476 Term: Elevated cholesterol
- Registration Number
- EUCTR2006-005513-35-FR
- Lead Sponsor
- aboratoires Merck Sharp & Dohme - Chibret
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1200
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
Female pregnant or lactating
Patient with Heart Failure NYHA Class III and IV
Myocradial infarction, coronary arthery by-pass surgery or angioplasthy within 3 months before V1
HBA1c uncontrolled > 8.5 %
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