CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 786 enrolled
Drug / intervention
ezetimibe (+) simvastatin +2 moredrug
Likely dose
ezetimibe (+) simvastatin 40mgfrom 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.

Search/NCT00462748
NCT00462748Phase 3Completed

A MC, DB, Rand, Study to Evaluate Efficacy, Safety and Tolerability of Eze/Simva 10/40 mg, Atorva 40 mg, Rosuva 10 mg in Achieving LDL-C <2 mmol/l in Pts With CVD...on Simva 40 mg With LDL-C ³2 mmol/l

Organon and Co·interventional·Posted Apr 19, 2007·Updated May 16, 2024

In Brief

A Phase 3 clinical trial evaluating ezetimibe (+) simvastatin, Comparator: atorvastatin, and 1 other intervention for Hypercholesterolemia. Completed, enrolled 786 participants.

Detailed Summary

To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C \> 2mmol/l, who are able to attain the recommended LDL-C target of \< 2mmol/l following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 19, 2007
Enrollment StartMar 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.2 years ago

Interventions

ezetimibe (+) simvastatindrug

ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.

Comparator: atorvastatindrug

atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally

Comparator: rosuvastatindrug

rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.