TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
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).
Drug: MK-0653, ezetimibe
Drug: Duration of Treatment: 3 months
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ezetimibe Together With Any Statin Cholesterol Enhancement|
- Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).
- Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.
|Study Start Date:||June 2004|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328523
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|