Open Label Study of Long Term Safety Evaluation of Alirocumab
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/26/2018 |
| Start Date: | December 17, 2013 |
| End Date: | June 30, 2017 |
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:
- To evaluate the long-term efficacy of alirocumab on lipid parameters.
- To evaluate the long-term immunogenicity of alirocumab.
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:
- To evaluate the long-term efficacy of alirocumab on lipid parameters.
- To evaluate the long-term immunogenicity of alirocumab.
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.
We found this trial at
45
sites
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