A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination tablets Ezetimibe/Simvastatin 10mg/20mg and Ezetimibe/Simvastatin 10mg/40mg compared to Atorvastatin 20mg in Patients with Type II Diabetes.
- Conditions
- hypercholesterolemyMedDRA version: 6.1Level: HLTClassification code 10014476
- Registration Number
- EUCTR2004-003000-37-IT
- Lead Sponsor
- MERCK SHARP DOHME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In patients already taking Atorvastatin 10 mg daily, with Type II diabetes, where the investigator feels that further cholesterol lowering therapy is appropriate, to determine the additional LDL-C lowering achieved by switching to Ezetimibe/Simvastatin 10mg/40mg, 10mg/20mg compared to double the dose of Atorvastatin 20mg .;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method