Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2012 |
| End Date: | January 2015 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia and LDL-C Higher or Equal to 160mg/dL With Their Lipid-Modifying Therapy
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9
(proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To evaluate the effect of alirocumab 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 in comparison with placebo on LDL-C at other time
points
- To evaluate the effects of alirocumab on other lipid parameters
- To evaluate the safety and tolerability of alirocumab
(proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To evaluate the effect of alirocumab 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 in comparison with placebo on LDL-C at other time
points
- To evaluate the effects of alirocumab on other lipid parameters
- To evaluate the safety and tolerability of alirocumab
The maximum study duration was planned to be 89 weeks per participant including participants
who successfully completed the 78-week treatment period had the possibility to join an
open-label extension study (LTS13463, NCT01954394) at the end of the treatment period.
who successfully completed the 78-week treatment period had the possibility to join an
open-label extension study (LTS13463, NCT01954394) at the end of the treatment period.
Inclusion criteria:
- Participants with heterozygous familial hypercholesterolemia who were not adequately
controlled with their lipid-modifying therapy.
Exclusion criteria:
- Age < 18 years
- LDL-C < 160 mg/dL (< 4.14 mmol/L) at the screening visit (Week-3).
- Fasting serum triglycerides > 400 mg/dL (> 4.52 mmol/L) during the screening period.
- Known history of homozygous familial hypercholesterolemia.
The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
We found this trial at
12
sites
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