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
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
Primary Objective:
To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).
Secondary Objectives:
The maximum study duration will be 176 weeks per participant.
Inclusion criteria:
Participants with heFH who had 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Caba, C1119ACN, Argentina
Praha 5 - Motol, 15006, Czechia
Frankfurt A.M., 60596, Germany