NL-OMON39858
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727/Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy - EFC12492 / Odessey FH1
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- familial hypercholesterolemia
- Sponsor
- Sanofi-aventis
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid\-modifying therapy.
Exclusion Criteria
- •\- Age \< 18 years
- •\- Patient without diagnosis of heFH made either by genotyping or by clinical criteria.
- •\- LDL\-C \<70 mg/dL (\<1\.81 mmol/L) at the screening visit (Week\-2\) and patient with history of documented cardiovascular disease.
- •\- LDL\-C \<100 mg/dL (\<2\.59 mmol/L) at the screening visit (Week\-2\) and patient without history of documented cardiovascular disease.
Outcomes
Primary Outcomes
Not specified
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