CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 314 enrolled
Drug / intervention
Atorvastatin +3 moredrug
Likely dose
Alirocumab 1 mLfrom 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/NCT01709513
NCT01709513Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Primary Hypercholesterolemia Who Are Intolerant to Statins

Regeneron Pharmaceuticals·interventional·Posted Oct 18, 2012·Updated Jun 23, 2020

In Brief

A Phase 3 clinical trial evaluating Atorvastatin, Ezetimibe, and 2 other interventions for Hypercholesterolemia. Completed, enrolled 314 participants across 70 sites in 8 countries.

Detailed Summary

This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesAustria, Canada, France, Israel, Italy, Norway, United Kingdom, United States
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2012
Enrollment StartSep 30, 2012
Primary CompletionMay 31, 2014
Study CompletionMay 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.7 years ago

Interventions

Atorvastatindrug

Atorvastatin over-encapsulated tablets.

Ezetimibedrug

Ezetimibe over-encapsulated tablet.

Alirocumabdrug

Alirocumab SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.

Placebodrug

Placebo for alirocumab, ezitimibe and atorvastatin.