CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 406 enrolled
Drug / intervention
Atorvastatin +5 moredrug
Likely dose
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/NCT01370590
NCT01370590Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Active-Controlled, Multicenter, Crossover Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin 10 mg/20 mg Fixed-Dose Combination Tablet Compared to Co-administration of Marketed Ezetimibe 10 mg and Atorvastatin 20 mg in Patients With Primary Hypercholesterolemia

Organon and Co·interventional·Posted Jun 10, 2011·Updated Feb 9, 2022

In Brief

A Phase 3 clinical trial evaluating Atorvastatin, Ezetimibe, and 4 other interventions for Hypercholesterolemia. Completed, enrolled 406 participants.

Detailed Summary

The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/20 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 20 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 10, 2011
Enrollment StartSep 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.1 years ago

Interventions

Atorvastatindrug

20 mg tablet administered orally once daily

Ezetimibedrug

10 mg tablet administered orally once daily

Ezetimibe/atorvastatindrug

Ezetimibe/atorvastatin 10 mg/20 mg combination tablet administered orally once daily

Placebo to atorvastatindrug

Administered orally once daily

Placebo to ezetimibedrug

Administered orally once daily

Placebo to ezetimibe/atorvastatindrug

Administered orally once daily