Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatment alirocumab sar236553 (regn727)
Phase phase 3
Sponsor Sanofi
Collaborator Regeneron Pharmaceuticals
Start date December 2013
End date June 2017
Trial size 1000 participants
Trial identifier NCT01954394, 2013-002572-40, LTS13463, U1111-1143-3810

Summary

Primary Objective:

To assess the long-term safety of alirocumab when added to lipid-lowering therapy in patients with heterozygous familial hypercholesterolemia (heFH).

Secondary Objectives:

To evaluate the long-term efficacy of alirocumab on lipid parameters. To evaluate the long-term immunogenicity of alirocumab.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Injection through subcutaneous (SC) administration
alirocumab sar236553 (regn727) Praluent
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Primary Outcomes

Measure
Assessment of safety parameters (adverse events, laboratory data, vital signs)
time frame: Up to 176 weeks

Secondary Outcomes

Measure
Percent change from baseline in low density lipoprotein cholesterol (LDL-C)
time frame: Up to 168 weeks
Percent change from baseline in other lipid parameters
time frame: Up to 168 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: Patients with heFH who have completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717). Exclusion criteria: Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Additional Information

Official title 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
Description The maximum study duration will be 176 weeks per patient.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Sanofi.