Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:7/29/2018
Start Date:December 16, 2013
End Date:June 30, 2017

Use our guide to learn which trials are right for you!

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients With Primary Hypercholesterolemia Not Treated With a Statin

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of
Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin
lipid modifying background therapy or as monotherapy in comparison with placebo in
participants with primary hypercholesterolemia not treated with a statin.

Secondary Objective:

- To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus
placebo.

- To evaluate the safety and tolerability of Alirocumab 150 mg Q4W.

Alirocumab 75 mg Q2W was added as a calibrator arm.

The core study duration was approximately 35 weeks per participant (screening: 3 weeks,
double-blind treatment period: 24 weeks; follow-up: 8 weeks). Participants who successfully
completed the treatment period had the possibility to participate in an optional open-label
treatment period with Alirocumab 150 mg Q4W until second quarter 2017 or until the drug is
commercially available in the country, whatever occurred first.

Inclusion criteria:

Participants with primary hypercholesterolemia (heterozygous familial hypercholesterolemia
[heFH] or non-FH) not adequately controlled with their non-statin LMT (either ezetimibe or
fenofibrate) or diet alone.

Exclusion criteria:

- LDL-C <70 mg/dL (1.81 mmol/L) at screening for statin intolerant participants at very
high cardiovascular (CV) risk;

- LDL-C <100 mg/dL (<2.59 mmol/L) at screening for statin intolerant participants at
high or moderate CV risk or, participants not fulfilling the statin intolerant
definition at moderate CV risk;

- LDL-C ≥160 mg/dL (≥4.1 mmol/L) at screening for participants receiving diet only or,
participants not fulfilling the statin intolerant definition at moderate CV risk and
receiving a non-statin LMT.

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
9
sites
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Ashford,
Click here to add this to my saved trials
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Fall River, Massachusetts 02720
?
mi
from
Fall River, MA
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Summerville, South Carolina 29485
?
mi
from
Summerville, SC
Click here to add this to my saved trials