Trial intelligence / Profile preview

Alirocumab in Japanese HeFH or High CV Risk Patients

NCT02107898Phase 3

Key facts

Status: Completed
Start: Mar 2014
Primary completion: Jan 2015
Countries: 1
Sponsor: Sanofi
Modality: Monoclonal Antibodies

Drugs: alirocumab
Conditions: heterozygous familial hypercholesterolemia (HeFH)hypercholesterolemia

Overview

Phase 3, randomised, double-blind trial in heterozygous familial hypercholesterolemia (HeFH) and hypercholesterolemia comparing Placebo Q2W with Alirocumab 75/150 mg Q2W (2 arms). Primary endpoint: Percent Change From Baseline in Calculated Low-Density Lipoprotein Cholesterol at 24 weeks. Started Mar 2014; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Placebo Q2W
Placebo Q2W + Stable LMT
Alirocumab 75/150 mg Q2W
Alirocumab 75 mg Q2W (up-titrate to 150 mg if needed) + Stable LMT

Endpoints

Primary

Percent Change From Baseline in Calculated Low-Density Lipoprotein Cholesterol24 weeks

Secondary

Percent Change From Baseline in Calculated Low-Density Lipoprotein Cholesterol52 weeks
Percent Change From Baseline in Apolipoprotein B24 weeks
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol24 weeks
Percent Change From Baseline in Total Cholesterol24 weeks
Percentage of Participants Reaching Calculated LDL-C Goal24 weeks
Percent Change From Baseline in Lipoprotein (a)24 weeks
Percent Change From Baseline in Fasting Triglycerides24 weeks
Percent Change From Baseline in High Density Lipoprotein Cholesterol24 weeks

Results

Primary endpoints met

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