CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 250 enrolled
Drug / intervention
ezetimibe/simvastatin 10/40 +2 moredrug
Likely dose
atorvastatin 40 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/NCT00782184
NCT00782184Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin

Organon and Co·interventional·Posted Oct 31, 2008·Updated May 16, 2024

In Brief

A Phase 3 clinical trial evaluating ezetimibe/simvastatin 10/40, atorvastatin 40 mg, and 1 other intervention for Hypercholesterolemia. Completed, enrolled 250 participants.

Detailed Summary

Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2008
Enrollment StartNov 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.7 years ago

Interventions

ezetimibe/simvastatin 10/40drug

ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.

atorvastatin 40 mgdrug

atorvastatin 40 mg tablet once daily for 6 weeks

atorvastatin 20 mgdrug

All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization