A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to evaluate the Efficacy and Safety of SAR236553 (REGN727) in Patients With Heterozygous Familial Hypercholesterolemia and LDL-C higher or equal to 160mg/dL with Their Lipid-Modifying Therapy
Phase 3
Completed
- Conditions
- familial hypercholesterolemiainherited hyperlipidemia100274241001331710003216
- Registration Number
- NL-OMON39914
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
Inclusion Criteria
Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid-modifying therapy.
Exclusion Criteria
- Age < 18 years;- LDL-C < 160 mg/dL (< 4.14 mmol/L) at the screening visit (Week-2).;- Fasting serum triglycerides > 400 mg/dL (> 4.52 mmol/L) during the screening period.;- Known history of homozygous familial hypercholesterolemia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The percent change in calculated LDL-C from baseline to week 24, which is<br /><br>defined as : 100x (calculated LDL-C value at week 24 - calculated LDL-C value<br /><br>at baseline) / calculated LDL-C value at baseline.<br /><br>The baseline calculated LDL-C value will be the last LDL-C level obtained<br /><br>before the first double-blind IMP injection.</p><br>
- Secondary Outcome Measures
Name Time Method