CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 986 enrolled
Drug / intervention
Alirocumab +1 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/NCT01954394
NCT01954394Phase 3Completed
CompareCT.gov

Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia

Sanofi·interventional·Posted Oct 1, 2013·Updated Jul 24, 2018

In Brief

A Phase 3 clinical trial evaluating Alirocumab and Lipid-Modifying Therapy (LMT) for Hypercholesterolemia. Completed, enrolled 986 participants across 177 sites in 24 countries.

Detailed Summary

Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831). Secondary Objectives: * To evaluate the long-term efficacy of alirocumab on lipid parameters. * To evaluate the long-term immunogenicity of alirocumab.

Study Details

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

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 1, 2013
Enrollment StartDec 17, 2013
Primary CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.8 years ago

Interventions

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.