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
Phase 3
Completed
- Conditions
- 100032161002742410013317familial hypercholesterolemiainherited hyperlipidemia
- Registration Number
- NL-OMON39858
- 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
- 18
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by<br /><br>SAR236553/Alirocumab as add-on therapy to stable maximally tolerated daily<br /><br>statin therapy with or without other lipid-modifying therapy (LMT) in<br /><br>comparison with placebo after 24 weeks of treatment in patients with<br /><br>heterozygous familial hypercholesterolemia (heFH).</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To evaluate the effect of SAR236553/Alirocumab 75 mg in comparison with<br /><br>placebo on LDL-C after 12 weeks of treatment.<br /><br>- To evaluate the effect of SAR236553/Alirocumab on other lipid parameters (ie,<br /><br>apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C),<br /><br>total cholesterol (total-C), lipoprotein (a) (Lp (a)), high-density lipoprotein<br /><br>cholesterol (HDL-C), triglyceride (TG) levels, apolipoprotein A-1 (Apo A-1)<br /><br>levels.<br /><br>- To evaluate the long-term effect of SAR236553/Alirocumab on LDL-C.<br /><br>- To evaluate the safety and tolerability of SAR236553/Alirocumab.<br /><br>- To evaluate the development of anti-SAR236553/Alirocumab antibodies.<br /><br>- To evaluate the pharmacokinetics (PK) of SAR236553/Alirocumab.</p><br>