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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT02023879
First received: December 6, 2013
Last updated: July 22, 2014
Last verified: July 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: May 2016
Estimated Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 43 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: July 22, 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 September 18, 2014