Open Label Study of Long Term Safety Evaluation of Alirocumab (ODYSSEY OLE)
To assess the long-term safety of alirocumab when added to lipid-lowering therapy in patients with heterozygous familial hypercholesterolemia (heFH).
To evaluate the long-term efficacy of alirocumab on lipid parameters. To evaluate the long-term immunogenicity of alirocumab.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Assessment of safety parameters (adverse events, laboratory data, vital signs) [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: Yes ]
- Percent change from baseline in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
- Percent change from baseline in other lipid parameters [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Injection through subcutaneous (SC) administration
Drug: Alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
The maximum study duration will be 120 weeks per patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01954394
|Contact: For site information, send an email with site number to||Contact-Us@sanofi.com|
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|Study Director:||Clinical Sciences & Operations||Sanofi|