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Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)

NCT02023879 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2018-07-27

Study results available
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Summary

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin.

Secondary Objective:

* To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo.
* To evaluate the safety and tolerability of Alirocumab 150 mg Q4W.

Alirocumab 75 mg Q2W was added as a calibrator arm.

Conditions

Interventions

DRUG

Alirocumab

Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).

DRUG

Placebo (for Alirocumab)

Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).

DRUG

Non-statin LMT

Ezetimibe or Fenofibrate at stable dose as background therapy.

OTHER

Diet Alone

Stable cholesterol-lowering diet as background therapy.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-16
Primary Completion
2014-10-27
Completion
2017-06-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • Netherlands
  • New Zealand
  • Spain

Study Locations

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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 NCT02023879 on ClinicalTrials.gov