CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 355 enrolled
Drug / intervention
Alirocumab +4 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/NCT01730040
NCT01730040Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind Study of the Efficacy and Safety of Alirocumab Added on to Atorvastatin Versus Ezetimibe Added on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin

Regeneron Pharmaceuticals·interventional·Posted Nov 21, 2012·Updated Aug 31, 2015

In Brief

A Phase 3 clinical trial evaluating Alirocumab, Atorvastatin, and 3 other interventions for Hypercholesterolemia. Completed, enrolled 355 participants across 97 sites in 9 countries.

Detailed Summary

This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesAustralia, Canada, France, Germany, Italy, Mexico, Spain, United Kingdom, United States
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2012
Enrollment StartOct 1, 2012
Primary CompletionApr 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.6 years ago

Interventions

Alirocumabdrug

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

Atorvastatindrug

Atorvastatin over-encapsulated tablets orally.

Ezetimibedrug

Ezetimibe over-encapsulated tablet orally.

Rosuvastatindrug

Rosuvastatin over-encapsulated tablets orally.

Placebodrug

Placebo for alirocumab and ezetimibe.