Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatments alirocumab, placebo (for alirocumab), ezetimibe, placebo (for ezetimibe), statin therapy
Phase phase 3
Sponsor Sanofi
Collaborator Regeneron Pharmaceuticals
Start date August 2012
End date May 2014
Trial size 720 participants
Trial identifier NCT01644188, 2011-004130-34, EFC11569, U1111-1121-4315

Summary

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in patients with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

- To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points.

- To evaluate the effect of alirocumab on other lipid parameters.

- To evaluate the safety and tolerability of alirocumab.

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)
Alirocumab injection through subcutaneous (SC) administration + placebo (for ezetimibe) orally. Background statin therapy continued during the course of the trial.
alirocumab SAR236553
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
placebo (for ezetimibe)
Pharmaceutical form: Capsules Route of administration: Oral
statin therapy
Atorvastatin, rosuvastatin or simvastatin at stable dose
(Active Comparator)
Placebo (for alirocumab) injection through subcutaneous (SC) administration + ezetimibe orally. Background statin therapy continued during the course of the trial.
placebo (for alirocumab)
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
ezetimibe
Pharmaceutical form: Encapsulated tablets Route of administration: Oral
statin therapy
Atorvastatin, rosuvastatin or simvastatin at stable dose

Primary Outcomes

Measure
Percent change in calculated LDL-C at Week 24
time frame: From baseline to Week 52

Secondary Outcomes

Measure
Percent change in calculated LDL-C at Week 12 and 52
time frame: From baseline up to Week 52
Percent change in other lipid parameters at Week 12, Week 24 and 52
time frame: From baseline up to Week 52
Percent change in calculated LDL-C at Week 104
time frame: From baseline up to Week 104
Percent change in other lipid parameters at Week 104
time frame: From baseline up to Week 104

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2). Exclusion criteria: - Age < 18 or legal age of adulthood, whichever is greater. - Patients without established CHD or CHD risk equivalents. - LDL-C <70 mg/dL (<1.81 mmol/L) and patients with a history of documented cardiovascular disease. - LDL-C <100 mg/dL (<2.59 mmol/L) and patients without a history of documented CV disease. - Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Additional Information

Official title A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy
Description The maximum study duration will be 115 weeks per patient, including a 3 week screening period, 104 week randomized treatment period and 8 week follow-up period.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Sanofi.