CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,341 enrolled
Drug / intervention
Placebo (for alirocumab) +2 moredrug
Likely dose
Not stated in 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/NCT01507831
NCT01507831Phase 3Completed
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Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study

Sanofi·interventional·Posted Jan 11, 2012·Updated Dec 22, 2015

In Brief

A Phase 3 clinical trial evaluating Placebo (for alirocumab), Alirocumab, and 1 other intervention for Hypercholesterolemia. Completed, enrolled 2,341 participants across 320 sites in 27 countries.

Detailed Summary

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: * To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. * To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. * To evaluate the effects of alirocumab on other lipid parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesArgentina, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2012
Enrollment StartJan 1, 2012
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.5 years ago

Interventions

Placebo (for alirocumab)drug

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.

Alirocumabdrug

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.

Lipid-Modifying Therapy (LMT)drug

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.