NL-OMON36881CompletedPhase 3
A Randomized, Double-Blind, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 over 24 weeks in Patients with Hypercholesterolemia - EFC11716
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi-aventis
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Patients with hypercholesterolemia at moderate cardio-vascular (CV) risk defined with a 10-year risk SCORE >=1% and < 5% based on the Systematic Coronary Risk Estimation (SCORE)
Exclusion Criteria
- •* Age < 18 or legal age of adulthood, whichever is greater
- •* LDL-C < 100 mg/dL (< 2.59 mmol/L) or > 190 mg/dL (> 4.9 mmol/L)
- •* Fasting serum TG > 400 mg/dL > 4.52 mmol/L)
- •* Known history of homozygous or heterozygous familial hypercholesterolemia
Investigators
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