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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01954394
First Posted: October 1, 2013
Last Update Posted: December 15, 2016
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.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
September 16, 2013
October 1, 2013
December 15, 2016
December 2013
June 2017   (Final data collection date for primary outcome measure)
Assessment of safety parameters (adverse events, laboratory data, vital signs) [ Time Frame: Up to 176 weeks ]
Assessment of safety parameters (adverse events, laboratory data, vital signs) [ Time Frame: Up to 120 weeks ]
Complete list of historical versions of study NCT01954394 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percent change from baseline in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Up to 120 weeks ]
  • Percent change from baseline in other lipid parameters [ Time Frame: Up to 120 weeks ]
Not Provided
Not Provided
 
Open Label Study of Long Term Safety Evaluation of Alirocumab
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

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.

The maximum study duration will be 176 weeks per patient.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypercholesterolemia
Drug: Alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Other Name: Praluent
Experimental: Alirocumab
Injection through subcutaneous (SC) administration
Intervention: Drug: Alirocumab SAR236553 (REGN727)
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
1000
June 2017
June 2017   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Belgium,   Bulgaria,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Mexico,   Netherlands,   Norway,   Portugal,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT01954394
LTS13463
2013-002572-40 ( EudraCT Number )
U1111-1143-3810 ( Other Identifier: UTN )
Yes
Not Provided
Not Provided
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
December 2016

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