Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatments alirocumab, placebo
Phase phase 3
Sponsor Regeneron Pharmaceuticals
Collaborator Sanofi
Start date October 2013
End date September 2014
Trial size 803 participants
Trial identifier NCT01926782, R727-CL-1308

Summary

The purpose of the study is to determine if the study drug (alirocumab)administered every 4 weeks, given by injection under the skin is effective and safe compared with placebo in lowering cholesterol, if used alone or added to the participants' current cholesterol-lowering medication.

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)
dosing regimen 1
alirocumab
(Experimental)
dosing regimen 2
alirocumab
(Placebo Comparator)
Placebo matching alirocumab
placebo

Primary Outcomes

Measure
Percent change in calculated LDL-C with concomitant statins
time frame: baseline to week 24
Percent change in calculated LDL-C without concomitant statins
time frame: baseline to week 24

Secondary Outcomes

Measure
Percent change in calculated LDL-C
time frame: baseline to week 12
Percent change in ApoB
time frame: baseline to week 24
Percent change in non- HDL-C
time frame: baseline to week 24
Percent change in total cholesterol
time frame: baseline to week 24
Percent change in ApoB
time frame: baseline to week 12
Percent change in non-HDL-C
time frame: baseline to week 12
Percent change in total cholesterol
time frame: baseline to week 12
Proportion of patients reaching LDL-C goal
time frame: at week 24
Proportion of patients reaching LDL-C <70 mg/dL
time frame: at week 24
Proportion of patients reaching LDL-C <100 mg/dL
time frame: at week 24
Percent change in Lp(a)
time frame: baseline to week 24
Percent change in HDL-C
time frame: baseline to week 24
Percent change in Lp(a)
time frame: baseline to week 12
Percent change in HDL-C
time frame: baseline to week 12
Percent change in fasting TG
time frame: baseline to week 24
Percent change in ApoA-1
time frame: baseline to week 24
Percent change in fasting TG
time frame: baseline to week 12
Percent change in ApoA-1
time frame: baseline to week 12

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Men and women > age 18 or legal age of majority with elevated LDL-C 2. Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide signed informed consent Exclusion Criteria: 1. Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease 2. Known history of positive test for human immunodeficiency virus (HIV) 3. Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or patients with short life expectancy. 4. Patients considered by the investigator or any sub-investigator to be inappropriate for this study (e.g, geographic or social), actual or anticipated, that the investigator feels would restrict or limit the patient's participation for the duration of the study. 5. Certain laboratory findings obtained during the screening period The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Regeneron Pharmaceuticals.