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: June 27, 2013
Last verified: May 2013

June 15, 2012
June 27, 2013
July 2012
December 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 NCT01623115 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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

Primary Objective:

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

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 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

  • Other: placebo
    Pharmaceutical form:Solution for injection Route of administration: subcutaneous
  • Experimental: alirocumab SAR236553 (REGN727)

    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 SAR236553 (REGN727)
  • 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
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
471
December 2014
December 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'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,   Austria,   Canada,   Czech Republic,   Denmark,   France,   Israel,   Netherlands,   Norway,   Russian Federation,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT01623115
EFC12492, U1111-1121-4275
Yes
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
May 2013

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