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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01954394
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : December 8, 2017
Regeneron Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Alirocumab SAR236553 (REGN727) Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 987 participants
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
Actual Study Start Date : December 17, 2013
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: Alirocumab
Injection through subcutaneous (SC) administration
Drug: Alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Other Name: Praluent

Primary Outcome Measures :
  1. Assessment of safety parameters (adverse events, laboratory data, vital signs) [ Time Frame: Up to 176 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01954394

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

Responsible Party: Sanofi Identifier: NCT01954394     History of Changes
Other Study ID Numbers: LTS13463
2013-002572-40 ( EudraCT Number )
U1111-1143-3810 ( Other Identifier: UTN )
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs