CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,289 enrolled
Drug / intervention
Atorvastatin 10 mg +4 moredrug
Likely dose
Atorvastatin 10 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/NCT00535405
NCT00535405Phase 3Completed

A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease

Organon and Co·interventional·Posted Sep 26, 2007·Updated May 16, 2024

In Brief

A Phase 3 clinical trial evaluating Atorvastatin 10 mg, Ezetimibe 10 mg/simvastatin 20 mg, and 3 other interventions for Hypercholesterolemia. Completed, enrolled 1,289 participants.

Detailed Summary

A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 26, 2007
Enrollment StartNov 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.8 years ago

Interventions

Atorvastatin 10 mgdrug

Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Ezetimibe 10 mg/simvastatin 20 mgdrug

Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks

Atorvastatin 20 mgdrug

Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Ezetimibe 10 mg/simvastatin 40 mgdrug

Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks

Atorvastatin 40 mgdrug

Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks