At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 618 enrolled
Drug / intervention
ezetimibe (+) simvastatin +3 moredrug
Likely dose
ezetimibe (+) simvastatin 20mgfrom 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 Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment
In Brief
A Phase 3 clinical trial evaluating ezetimibe (+) simvastatin, Comparator : rosuvastatin calcium, and 1 other intervention for Hypercholesterolemia. Completed, enrolled 618 participants.
Detailed Summary
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedMay 2007
Primary CompletionMar 2008
TodayJul 2026
First PostedMay 28, 2007
Enrollment StartFeb 1, 2007
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.1 years ago
Interventions
ezetimibe (+) simvastatindrug
ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.
Comparator : rosuvastatin calciumdrug
rosuvastatin 10mg. The treatment duration will be 6 weeks.
Comparator: Placebo (unspecified)drug
rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.
Comparator: Placebo (unspecified)drug
ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.