TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
NCT00328523 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1496
Last updated 2024-08-15
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).
Conditions
- Hypercholesterolaemia
- Hyperlipidaemia
Interventions
- DRUG
-
MK-0653, ezetimibe
- DRUG
-
Duration of Treatment: 3 months
Sponsors & Collaborators
-
Organon and Co
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-06-30
- Primary Completion
- 2006-01-31
- Completion
- 2006-01-31
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