Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatments alirocumab (regn727/ sar236553), active comparator 1 (ezetimibe), active comparator 2 (atorvastatin), placebo 1 (placebo for ezetimibe atorvastatin), placebo 2 [alirocumab (regn727/ sar236553)]
Phase phase 3
Sponsor Regeneron Pharmaceuticals
Collaborator Sanofi
Start date September 2012
End date March 2014
Trial size 314 participants
Trial identifier NCT01709513, R727-CL-1119

Summary

This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study of alirocumab (REGN727/ SAR236553) in patients with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
alirocumab (REGN727/ SAR236553) and Placebo 1 (placebo for ezetimibe atorvastatin)
alirocumab (regn727/ sar236553)
placebo 1 (placebo for ezetimibe atorvastatin)
(Experimental)
Active Comparator 1 (ezetimibe) and Placebo 2 [(placebo for alirocumab (REGN727/ SAR236553)]
active comparator 1 (ezetimibe)
placebo 2 [alirocumab (regn727/ sar236553)]
(Experimental)
Active Comparator 2 (atorvastatin) and Placebo 2 [(placebo for alirocumab (REGN727/ SAR236553)]
active comparator 2 (atorvastatin)
placebo 2 [alirocumab (regn727/ sar236553)]

Primary Outcomes

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

Secondary Outcomes

Measure
Percent change in calculated LDL-C to wk 12
time frame: Baseline to WK 12
Percent change in ApoB, non-HDL-C, total-C, HDL-C, Lp(a), TG, and Apo A-1 to time points up to wk 24
time frame: Baseline to Wk 24
Proportion of patients reaching LDL-C less than 70 mg/dL
time frame: At Wk 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients with primary hypercholesterolemia [Heterozygous Familial Hypercholesterolemia (heFH) or non-FH] with moderate, high or very high CV risk and a history of statin intolerance 2. Provide signed informed consent Exclusion Criteria: 1. Calculated serum LDL-C less than 70 mg/dL (1.81 mmol/L) and very high CV risk at the screening visit 2. Calculated serum LDL-C less than 100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the screening visit 3. A 10-year fatal cardiovascular disease risk score less than 1% at the screening visit (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, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Primary Hypercholesterolemia Who Are Intolerant to Statins
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Regeneron Pharmaceuticals.