Efficacy and Safety of Alirocumab SAR236553 (REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Combo II)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01644188
First received: July 16, 2012
Last updated: August 25, 2014
Last verified: August 2014

July 16, 2012
August 25, 2014
August 2012
August 2014   (final data collection date for primary outcome measure)
Percent change in LDL-C [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01644188 on ClinicalTrials.gov Archive Site
  • Percent change in LDL-C [ Time Frame: From baseline up to week 12 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Alirocumab SAR236553 (REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Combo II)
A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab SAR236553 (REGN727) as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in patients with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

  • To evaluate the effect of alirocumab SAR236553 (REGN727) in comparison with ezetimibe on LDL-C at other time points.
  • To evaluate the effect of alirocumab SAR236553 (REGN727) on other lipid parameters.
  • To evaluate the safety and tolerability of alirocumab SAR236553 (REGN727).

The maximum study duration will be 115 weeks per patient, including a 3 week screening period, 104 week randomized treatment period and 8 week follow-up period.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: alirocumab SAR236553 (REGN727)

    alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

    Pharmaceutical form:Solution for injection Route of administration: subcutaneous

  • Drug: matching placebo alirocumab SAR236553 (REGN727)
    Pharmaceutical form:Solution for injection Route of administration: subcutaneous
  • Drug: Ezetimibe
    Pharmaceutical form:encapsulated tablets Route of administration: oral
  • Drug: matching placebo for Ezetimibe
    Pharmaceutical form:capsules Route of administration: oral
  • Experimental: alirocumab SAR236553 (REGN727) / Ezetimibe placebo
    Injection through subcutaneous (SC) administration. Ezetimibe placebo is administered orally.
    Interventions:
    • Drug: alirocumab SAR236553 (REGN727)
    • Drug: matching placebo for Ezetimibe
  • Active Comparator: alirocumab SAR236553 (REGN727) Placebo / Ezetimibe
    Injection through subcutaneous (SC) administration. Ezetimibe is administered orally.
    Interventions:
    • Drug: matching placebo alirocumab SAR236553 (REGN727)
    • Drug: Ezetimibe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
660
July 2015
August 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria:

  • Age < 18 or legal age of adulthood, whichever is greater.
  • Patients without established CHD or CHD risk equivalents.
  • LDL-C <70 mg/dL (<1.81 mmol/L) and patients with a history of documented cardiovascular disease.
  • LDL-C <100 mg/dL (<2.59 mmol/L) and patients without a history of documented CV disease.
  • Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L).

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Denmark,   France,   Hungary,   Israel,   Korea, Republic of,   Russian Federation,   South Africa,   Ukraine
 
NCT01644188
EFC11569, U1111-1121-4315
Yes
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP