Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

Conditions

• Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Alirocumab — DRUG
  1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
• Placebo (for alirocumab) — DRUG
  1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
• Ezetimibe — DRUG
  One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.
• Placebo (for ezetimibe) — DRUG
  One capsule once daily orally at approximately the same time of the day with or without food.
• Lipid Modifying Therapy (LMT) — DRUG
  Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.

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 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 participants 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

Key Dates

Start date

Aug 31, 2012

Status verified

Jun 2016

Primary completion

May 31, 2014

Completion

Jul 31, 2015

Study Design

Enrollment

720 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Alirocumab 75 /up to 150 mg Q2W
  Alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
• Active Comparator: Ezetimibe 10 mg
  Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks.

Primary Outcome Measure

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis [ Time Frame: From Baseline to Week 52 ]

Locations (58)

Find similar trials in Birmingham, AL

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