Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Conditions

• Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo (for alirocumab) — DRUG
  Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
• Alirocumab — DRUG
  Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
• Lipid-Modifying Therapy (LMT) — DRUG
  Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Study Details

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: * To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. * To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. * To evaluate the effects of alirocumab on other lipid parameters.

Key Dates

Start date

Jan 31, 2012

Status verified

Nov 2015

Primary completion

Nov 30, 2014

Completion

Nov 30, 2014

Study Design

Enrollment

2,341 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 78 weeks.
• Experimental: Alirocumab
  Alirocumab 150 mg Q2W added to stable LMT for 78 weeks.

Primary Outcome Measure

Percentage of Participants Who Experienced Adverse Events (AEs) [ Time Frame: Up to 10 weeks after last study drug administration (maximum of 86 weeks) ]

Locations (115)

Find similar trials in Huntsville, AL

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