Overview

This trial is active, not recruiting.

Condition heterozygous familial hypercholesterolemia
Treatments lmt (atorvastatin, simvastatin, or rosuvastatin), alirocumab (regn727/ sar236553), placebo
Phase phase 3
Sponsor Regeneron Pharmaceuticals
Collaborator Sanofi
Start date December 2012
End date May 2014
Trial size 249 participants
Trial identifier NCT01709500, R727-CL-1112

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (REGN727/ SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
LMT (atorvastatin, simvastatin, or rosuvastatin) and alirocumab (REGN727/ SAR236553)
lmt (atorvastatin, simvastatin, or rosuvastatin)
alirocumab (regn727/ sar236553)
(Active Comparator)
LMT (atorvastatin, simvastatin, or rosuvastatin) and placebo
lmt (atorvastatin, simvastatin, or rosuvastatin)
placebo

Primary Outcomes

Measure
Percent change in LDL-C to week 24
time frame: Baseline to Wk 24

Secondary Outcomes

Measure
Percent change in LDL-C to weeks 12 and 52.
time frame: Baseline to Wks 12 and 52
Percent change in ApoB, non-HDL-C, total-C, HDL-C, Lp(a), TG, and Apo A-1
time frame: Baseline to Wks 12 and 24
Proportion of patients reaching LDL-C goal
time frame: At Wk 24
Proportion of patients reaching LDL-C <70 mg/dL (1.81 mmol/L)
time frame: At Wk 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patients with heFH who are not adequately controlled with their LMT Exclusion Criteria: 1. Age less than 18 years or legal age of adulthood, whichever is greater 2. LDL-C less than 70 mg/dL (1.81 mmol/L) and with cardiovascular disease 3. LDL-C less than 100 mg/dL (2.59 mmol/L) and without cardiovascular disease 4. Fasting serum triglycerides greater than 400 mg/dL (4.52 mmol/L) 5. Known history of homozygous familial hypercholesterolemia (The inclusion/exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Regeneron Pharmaceuticals.