NCT02715726

Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia

A Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 615 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at high cardiovascular (CV) risk. Secondary Objectives: * To evaluate the effect of alirocumab 75 mg in comparison with ezetimibe 10 mg on LDL-C after 12 weeks of treatment. * To evaluate the effect of alirocumab on other lipid parameters: e.g., apolipoprotein B (Apo B), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a (Lp\[a\]), HDL-C, triglycerides (TG), apolipoprotein A-1 (Apo A-1). * To evaluate the safety and tolerability of alirocumab. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetics (PK) of alirocumab.

Detailed description

The maximum study duration was 35 weeks per participant, which included a screening period of up to 3 weeks, a 24-week randomized treatment period, and an 8-week post-treatment follow-up period.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Alirocumab	Pharmaceutical form:solution Route of administration: subcutaneous
DRUG	Placebo for alirocumab	Pharmaceutical form:solution Route of administration: subcutaneous
DRUG	ezetimibe	Pharmaceutical form:capsule Route of administration: oral
DRUG	placebo for ezetimibe	Pharmaceutical form:capsule Route of administration: oral
DRUG	atorvastatin	Pharmaceutical form:tablet Route of administration: oral
DRUG	rosuvastatin	Pharmaceutical form:tablet Route of administration: oral
DRUG	simvastatin	Pharmaceutical form:tablet Route of administration: oral

Timeline

• Start date: 2016-07-27
• Primary completion: 2018-08-06
• Completion: 2018-08-06
• First posted: 2016-03-22
• Last updated: 2019-09-30
• Results posted: 2019-09-30

Locations

62 sites across 3 countries: China, India, Thailand

Regulatory

• FDA-regulated drug study