TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)
Information source: Merck
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolaemia; Hyperlipidaemia
Intervention: MK-0653, ezetimibe (Drug); Duration of Treatment: 3 months (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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).
Clinical Details
Official title: Ezetimibe Together With Any Statin Cholesterol Enhancement
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).
Secondary outcome: Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Laboratoires Merck Sharp & Dohme - Chibret, Paris 75114, France
Additional Information
Starting date: June 2004
Last updated: May 19, 2006
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