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

This study is ongoing, but not recruiting participants.
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi Identifier:
First received: September 16, 2013
Last updated: December 14, 2016
Last verified: December 2016

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: Intervention Model: Single Group Assignment
Masking: None (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 176 weeks ]

Secondary Outcome Measures:
  • Percent change from baseline in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Up to 168 weeks ]
  • Percent change from baseline in other lipid parameters [ Time Frame: Up to 168 weeks ]

Estimated Enrollment: 1000
Study Start Date: December 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (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
Other Name: Praluent

Detailed Description:
The maximum study duration will be 176 weeks per patient.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01954394

  Show 178 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT01954394     History of Changes
Other Study ID Numbers: LTS13463
2013-002572-40 ( EudraCT Number )
U1111-1143-3810 ( Other Identifier: UTN )
Study First Received: September 16, 2013
Last Updated: December 14, 2016

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017