At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 120 enrolled
Drug / intervention
Ezetimibe/Simvastatin 10/20 mg +1 moredrug
Likely dose
Ezetimibe/Simvastatin 10/20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Parallel-Groups, Double-Blind Placebo-Controlled Study Comparing the Efficacy, Safety, and Tolerability of Administration of Ezetimibe/Simvastatin Tablet 10/20 mg Versus Doubling the Dose of Simvastatin 20 mg [Simvastatin 40 mg] in Subjects With Primary Hypercholesterolemia and Coronary Heart Disease
In Brief
A Phase 4 clinical trial evaluating Ezetimibe/Simvastatin 10/20 mg and simvastatin 40 mg for Hypercholesterolemia and Coronary Disease. Completed, enrolled 120 participants.
Detailed Summary
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Coronary Disease
Countries--
CollaboratorsSchering-Plough
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedJan 2007
Primary CompletionMar 2008
TodayJul 2026
First PostedJan 18, 2007
Enrollment StartJul 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.5 years ago
Interventions
Ezetimibe/Simvastatin 10/20 mgdrug
1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks
simvastatin 40 mgdrug
1 tablet containing 40 mg of simvastatin per day for 6 weeks