CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 808 enrolled
Drug / intervention
ezetimibe (+) simvastatin +3 moredrug
Likely dose
simvastatin 40 mg or atorvastatin 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.

Search/NCT00862251
NCT00862251Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose

Organon and Co·interventional·Posted Mar 16, 2009·Updated May 16, 2024

In Brief

A Phase 3 clinical trial evaluating ezetimibe (+) simvastatin, simvastatin 40 mg or atorvastatin 20 mg, and 2 other interventions for Cardiovascular Disorder and Diabetes Mellitus. Completed, enrolled 808 participants.

Detailed Summary

The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Disorder, Diabetes Mellitus
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2009
Enrollment StartApr 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.3 years ago

Interventions

ezetimibe (+) simvastatindrug

ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.

simvastatin 40 mg or atorvastatin 20 mgdrug

simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.

Rosuvastatindrug

rosuvastatin 10 mg tablets, taken once daily for six weeks.

atorvastatin 10 mg or simvastatin 20 mgdrug

All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.