TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
Phase 3
Completed
- Conditions
- HypercholesterolaemiaHyperlipidaemia
- Registration Number
- NCT00328523
- Lead Sponsor
- Organon and Co
- Brief Summary
In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the recommended target goal (esc 2003 recommendations ldl\>=1.15 g/l) to compare the efficacy and the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient motivation on diet or physical activities or both).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1496
Inclusion Criteria
- Primary hypercholesterolemia treated with any statin at any dose, for at least 3 months with a ldl cholesterol above 115 mg/dl (esc 2003 recommendations).
Exclusion Criteria
- pregnant or breast feeding women
- Lipid-lowering agents including hmg-coa reductase inhibitors other than the current statin, fish oils, cholestyramin, niacin (>200 mg/day) and fibrates taken within the 3 months preceding visit 1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).
- Secondary Outcome Measures
Name Time Method Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.