Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | November 2014 |
Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study
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 long-term safety and tolerability of alirocumab in high cardiovascular risk
participants with hypercholesterolemia not adequately controlled with their current lipid
modifying therapy (LMT).
Secondary Objectives:
- To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C)
levels after 24 weeks of treatment in comparison with placebo.
- 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.
(proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk
participants with hypercholesterolemia not adequately controlled with their current lipid
modifying therapy (LMT).
Secondary Objectives:
- To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C)
levels after 24 weeks of treatment in comparison with placebo.
- 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.
The maximum study duration was to be 89 weeks per participant, including a 3-week screening
period, a 78-week randomized treatment period and 8-week follow-up period.
period, a 78-week randomized treatment period and 8-week follow-up period.
Inclusion criteria:
Either A or B below and who were not adequately controlled with their lipid-modifying
therapy:
A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without
established coronary heart disease (CHD) or CHD risk equivalents
OR
B) Participants with hypercholesterolemia together with established CHD or CHD risk
equivalents.
Exclusion criteria:
- Age < 18 years
- LDL-C <70 mg/dL (< 1.81 mmol/L)
- Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L)
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
We found this trial at
96
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials