Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

Conditions

• Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Alirocumab — DRUG
  Two SC injections in the abdomen only.
• Placebo (for alirocumab) — DRUG
  Two subcutaneous (SC) injections in the abdomen only.
• Atorvastatin — DRUG
  Orally once daily at a stable dose of 10 mg, 20 mg, or 40 mg as background therapy.

Study Details

Primary Objective: * To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo * To evaluate the safety and tolerability of alirocumab * To evaluate the development of anti-alirocumab antibodies * To evaluate the pharmacokinetics of alirocumab

Key Dates

Start date

Jan 31, 2011

Status verified

Aug 2015

Primary completion

Dec 31, 2011

Completion

Dec 31, 2011

Study Design

Enrollment

183 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo Q2W
  Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
• Experimental: Alirocumab 50 mg Q2W
  Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
• Experimental: Alirocumab 100 mg Q2W
  Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
• Experimental: Alirocumab 150 mg Q2W
  Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
• Experimental: Alirocumab 200 mg Q4W
  Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo Q2W for 12-weeks in combination with atorvastatin stable dose.
• Experimental: Alirocumab 300 mg Q4W
  Alirocumab 300 mg Q4W and alternating placebo Q2W for 12-weeks in combination with atorvastatin stable dose.

Primary Outcome Measure

Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis [ Time Frame: Baseline to Week 12 (LOCF) ]

Locations (38)

Find similar trials in Tempe, AZ

Related Studies

• Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
  PHASE2 · Recruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina
• Pharmacogenomic Informed Statin Prescribing
  Recruiting · VA Office of Research and Development · Indianapolis, Indiana
• Improving Lipid Optimization Quality and Treatment Options in ASCVD
  Enrolling By Invitation · Brigham and Women's Hospital · Boston, Massachusetts
• Vascular Intervention Strategies Trial for Alzheimer's
  PHASE2 · Not Yet Recruiting · University of Southern California · Los Angeles, California