Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy (ODYSSEY FH I)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01623115
First received: June 15, 2012
Last updated: October 6, 2014
Last verified: October 2014

June 15, 2012
October 6, 2014
July 2012
April 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 NCT01623115 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 78 [ Time Frame: From baseline up to Week 78 ] [ Designated as safety issue: No ]
    From a mixed-effect model including all LDL-C values collected up to Week 78
  • Percent change in other lipid parameters at Week 78 [ Time Frame: From baseline up to Week 78 ] [ Designated as safety issue: No ]
  • Percent change in LDL-C [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying 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 evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

  • To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
  • To evaluate the effects of alirocumab on other lipid parameters.
  • To evaluate the safety and tolerability of alirocumab.

The maximum study duration will be 89 weeks per patient, including a 78-week randomized treatment 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
  • Other: Placebo

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

  • Experimental: Alirocumab

    Injection through subcutaneous (SC) administration.

    Background statin therapy or other lipid lowering therapy will be administered according to site investigator discretion as background therapy.

    Intervention: Drug: Alirocumab
  • Placebo Comparator: Placebo

    Injection through subcutaneous (SC) administration.

    Background statin therapy or other lipid lowering therapy will be administered according to site investigator discretion as background therapy.

    Intervention: Other: Placebo
Kastelein JJ, Robinson JG, Farnier M, Krempf M, Langslet G, Lorenzato C, Gipe DA, Baccara-Dinet MT. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy: design and rationale of the ODYSSEY FH studies. Cardiovasc Drugs Ther. 2014 Jun;28(3):281-9. doi: 10.1007/s10557-014-6523-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
486
December 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid-modifying therapy

Exclusion criteria:

  • Age < 18 years or legal age of adulthood, whichever is greater -LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
  • LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
  • Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L)
  • Known history of homozygous familial hypercholesterolemia

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Canada,   Czech Republic,   Denmark,   France,   Israel,   Netherlands,   Norway,   Russian Federation,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
 
NCT01623115
EFC12492, U1111-1121-4275, 2011-005109-56
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