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

This study is currently recruiting participants.
Verified April 2014 by Sanofi
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT02023879
First received: December 6, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in patients with primary hypercholesterolemia not treated with a statin.

Secondary Objective:

To evaluate the safety and tolerability of alirocumab.


Condition Intervention Phase
Hypercholesterolemia
Drug: alirocumab SAR236553 (REGN727) Dose Regimen A
Drug: alirocumab SAR236553 (REGN727) Dose Regimen B
Drug: alirocumab matching placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients With Primary Hypercholesterolemia Not Treated With a Statin

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The percent change in LDL-C from baseline to Week 24 [ Time Frame: At 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety parameters (adverse events, cardiovascular events, laboratory data, vital signs, and ECG) assessed throughout the study [ Time Frame: From baseline up to week 24 ] [ Designated as safety issue: No ]
  • The percent change in Apolipoprotein B (ApoB) [ Time Frame: From baseline up to week 24 ] [ Designated as safety issue: No ]
  • The percent change in non-high density lipoprotein cholesterol (non-HDL-C) [ Time Frame: From baseline up to week 24 ] [ Designated as safety issue: No ]
  • The percent change in Total-Cholesterol (TC) [ Time Frame: From baseline up to week 24 ] [ Designated as safety issue: No ]
  • The percent change in Lipoprotein (a) (Lp[a]) [ Time Frame: From baseline up to week 24 ] [ Designated as safety issue: Yes ]
  • The percent change in high-density lipoprotein cholesterol (HDL-C) [ Time Frame: From baseline up to week 24 ] [ Designated as safety issue: No ]
  • The percent change in Triglyceride (TG) [ Time Frame: From baseline up to week 24 ] [ Designated as safety issue: No ]
  • The percent change in Apolipoprotein A-1 (Apo A-1) levels [ Time Frame: From baseline up to week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alirocumab SAR236553 (REGN727) Dose Regimen A
injection through subcutaneous (SC) administration
Drug: alirocumab SAR236553 (REGN727) Dose Regimen A
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Experimental: alirocumab SAR236553 (REGN727) Dose Regimen B
injection through subcutaneous (SC) administration
Drug: alirocumab SAR236553 (REGN727) Dose Regimen B
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Placebo Comparator: alirocumab SAR236553 (REGN727) placebo
placebo subcutaneous (SC) injection
Drug: alirocumab matching placebo
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Detailed Description:

Approximately 35 weeks + an optional open-label treatment period up to 120 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with primary hypercholesterolemia (heFH or non-FH) not adequately controlled with their non statin lipid modifying therapy or diet.

Exclusion criteria:

LDL-C <70 mg/dL (1.81 mmol/L) and very high cardiovascular risk patients who are intolerant to statins at the screening visit (Week-3, V1).

LDL-C <100 mg/dL (<2.59 mmol/L) and at high or moderate cardiovascular risk patients at the screening visit (Week-3, V1).

LDL-C ≥ 160 mg/dL (≥4.1 mmol/L) if receiving diet only or a non-statin LMT for patients not fulfilling the statin intolerant definition.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02023879

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 44 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02023879     History of Changes
Other Study ID Numbers: EFC13786, 2013-002659-14, U1111-1146-3517
Study First Received: December 6, 2013
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 22, 2014