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Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)

NCT01730040 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2015-08-31

Study results available
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Summary

This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).

Conditions

Interventions

DRUG

Alirocumab

Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.

DRUG

Atorvastatin

Atorvastatin over-encapsulated tablets orally.

DRUG

Ezetimibe

Ezetimibe over-encapsulated tablet orally.

DRUG

Rosuvastatin

Rosuvastatin over-encapsulated tablets orally.

DRUG

Placebo

Placebo for alirocumab and ezetimibe.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Italy
  • Mexico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01730040 on ClinicalTrials.gov