CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
Placebo +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/NCT02326220
NCT02326220Phase 3Completed
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia Undergoing Lipid Apheresis Therapy

Regeneron Pharmaceuticals·interventional·Posted Dec 29, 2014·Updated May 1, 2020

In Brief

A Phase 3 clinical trial evaluating Placebo and Alirocumab for Heterozygous Familial Hypercholesterolemia. Completed, enrolled 62 participants across 13 sites in 2 countries.

Detailed Summary

The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH) undergoing weekly or bi-weekly LDL apheresis therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeterozygous Familial Hypercholesterolemia
CountriesGermany, United States
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 29, 2014
Enrollment StartMar 31, 2015
Primary CompletionJan 31, 2016
Study CompletionApr 30, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.5 years ago

Interventions

Placebodrug

Alirocumabdrug