CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 163 enrolled
Drug / intervention
Alirocumab +4 moredrug
Likely dose
Atorvastatin 5 mgfrom 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/NCT02584504
NCT02584504Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin

Sanofi·interventional·Posted Oct 22, 2015·Updated Jan 23, 2019

In Brief

A Phase 3 clinical trial evaluating Alirocumab, Placebo, and 3 other interventions for Hypercholesterolemia. Completed, enrolled 163 participants across 30 sites.

Detailed Summary

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of treatment in participants with hypercholesterolemia. Secondary Objective: * To evaluate the effect of two treatment regimens of alirocumab on other lipid parameters: apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non HDL-C), total cholesterol (TC), lipoprotein (a) (Lp\[a\]), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and apolipoprotein A-1 (Apo A-1). * To evaluate the safety and tolerability of alirocumab administration. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab administration. * To evaluate the long-term safety in participants receiving open-label alirocumab administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesJapan
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 22, 2015
Enrollment StartNov 30, 2015
Primary CompletionApr 5, 2017
Study CompletionJan 9, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.7 years ago

Interventions

Alirocumabdrug

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.

Placebodrug

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.

Atorvastatindrug

Atorvastatin 5 mg tablet orally.

Non-statin Lipid-Modifying Therapydrug

Ezetimibe, Bezafibrate or Fenofibrate at stable dose as background therapy.

Diet Aloneother

Stable cholesterol-lowering diet as background therapy.