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Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

NCT01926782 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 803

Last updated 2017-03-21

Study results available
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Summary

To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.

Conditions

Interventions

DRUG

Placebo (for alirocumab)

Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.

DRUG

Alirocumab

Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.

DRUG

Statin

Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy

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
2013-09-30
Primary Completion
2014-09-30
Completion
2015-04-30

Countries

  • United States
  • Bulgaria
  • Canada
  • Hungary
  • Israel
  • Norway
  • Slovakia
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01926782 on ClinicalTrials.gov