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Open Label Study of Long Term Safety Evaluation of Alirocumab (ODYSSEY OLE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Sanofi
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01954394
First received: September 16, 2013
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

Primary Objective:

To assess the long-term safety of alirocumab when added to lipid-lowering therapy in patients with heterozygous familial hypercholesterolemia (heFH).

Secondary Objectives:

To evaluate the long-term efficacy of alirocumab on lipid parameters. To evaluate the long-term immunogenicity of alirocumab.


Condition Intervention Phase
Hypercholesterolemia
Drug: Alirocumab SAR236553 (REGN727)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Assessment of safety parameters (adverse events, laboratory data, vital signs) [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent change from baseline in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in other lipid parameters [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: December 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alirocumab
Injection through subcutaneous (SC) administration
Drug: Alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Detailed Description:

The maximum study duration will be 120 weeks per patient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with heFH who have completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).

Exclusion criteria:

Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study.

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: NCT01954394

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 175 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: NCT01954394     History of Changes
Other Study ID Numbers: LTS13463, 2013-002572-40, U1111-1143-3810
Study First Received: September 16, 2013
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014