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: October 27, 2014
Last verified: October 2014

July 16, 2012
October 27, 2014
August 2012
May 2014   (final data collection date for primary outcome measure)
Percent change in calculated LDL-C at Week 24 [ Time Frame: From baseline to Week 52 ] [ Designated as safety issue: No ]
From a mixed-effect model including all LDL-C values collected up to Week 52
Percent change in LDL-C [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01644188 on ClinicalTrials.gov Archive Site
  • Percent change in calculated LDL-C at Week 12 and 52 [ Time Frame: From baseline up to Week 52 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters at Week 12, Week 24 and 52 [ Time Frame: From baseline up to Week 52 ] [ Designated as safety issue: No ]
  • Percent change in calculated LDL-C at Week 104 [ Time Frame: From baseline up to Week 104 ] [ Designated as safety issue: No ]
    From a mixed-effect model including all LDL-C values collected up to Week 104
  • Percent change in other lipid parameters at Week 104 [ Time Frame: From baseline up to Week 104 ] [ Designated as safety issue: No ]
  • 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 ]
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

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

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab 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 in comparison with ezetimibe on LDL-C at other time points.
  • To evaluate the effect of alirocumab on other lipid parameters.
  • To evaluate the safety and tolerability of alirocumab.

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

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

    Other Names:
    • SAR236553
    • REGN727
  • Drug: Placebo (for alirocumab)

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

  • Drug: Ezetimibe

    Pharmaceutical form: Encapsulated tablets

    Route of administration: Oral

  • Drug: Placebo (for ezetimibe)

    Pharmaceutical form: Capsules

    Route of administration: Oral

  • Experimental: Alirocumab
    Alirocumab injection through subcutaneous (SC) administration + placebo (for ezetimibe) orally.
    Interventions:
    • Drug: Alirocumab
    • Drug: Placebo (for ezetimibe)
  • Active Comparator: Ezetimibe
    Placebo (for alirocumab) injection through subcutaneous (SC) administration + ezetimibe orally.
    Interventions:
    • Drug: Placebo (for alirocumab)
    • 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
May 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
Canada,   Denmark,   France,   Hungary,   Israel,   Korea, Republic of,   Russian Federation,   South Africa,   Ukraine,   United States
 
NCT01644188
EFC11569, U1111-1121-4315, 2011-004130-34
Yes
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
October 2014

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