Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:October 2013
End Date:May 2015
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com

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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia

The purpose of the study is to determine if the study drug (alirocumab)administered every 4
weeks, given by injection under the skin is effective and safe compared with placebo in
lowering cholesterol, if used alone or added to the participants' current
cholesterol-lowering medication.


Inclusion Criteria:

1. Men and women > age 18 or legal age of majority with elevated LDL-C

2. Patients not having adequate control of their hypercholesterolemia based on their
individual level of CVD risk

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent

Exclusion Criteria:

1. Recent (within 3 months prior to the screening visit) myocardial infarction, unstable
angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary
artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke,
transient ischemic attack, carotid revascularization, endovascular procedure or
surgical intervention for peripheral vascular disease

2. Known history of positive test for human immunodeficiency virus (HIV)

3. Any clinically significant abnormality identified at the time of screening that in
the judgment of the investigator or any sub-investigator would preclude safe
completion of the study or constrain assessment of endpoints, such as major systemic
diseases or patients with short life expectancy.

4. Patients considered by the investigator or any sub-investigator to be inappropriate
for this study (e.g, geographic or social), actual or anticipated, that the
investigator feels would restrict or limit the patient's participation for the
duration of the study.

5. Certain laboratory findings obtained during the screening period

The information listed above is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial and not all inclusion/ exclusion
criteria are listed.
We found this trial at
50
sites
2091
mi
from 02139
Salt Lake City, UT
Click here to add this to my saved trials
934
mi
from 02139
Atlanta, GA
Click here to add this to my saved trials
127
mi
from 02139
Auburn, ME
Click here to add this to my saved trials
1048
mi
from 02139
Birmingham, AL
Click here to add this to my saved trials
1758
mi
from 02139
Boerne, TX
Click here to add this to my saved trials
2250
mi
from 02139
Boise, ID
Click here to add this to my saved trials
1205
mi
from 02139
Boynton Beach, FL
Click here to add this to my saved trials
2613
mi
from 02139
Carmichael, CA
Click here to add this to my saved trials
2286
mi
from 02139
Chandler, AZ
Click here to add this to my saved trials
846
mi
from 02139
Chicago, IL
Click here to add this to my saved trials
735
mi
from 02139
Cincinnati, OH
Click here to add this to my saved trials
1192
mi
from 02139
Clearwater, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
1771
mi
from 02139
Colorado Springs, CO
Click here to add this to my saved trials
1546
mi
from 02139
Dallas, TX
Click here to add this to my saved trials
918
mi
from 02139
Evansville, IN
Click here to add this to my saved trials
640
mi
from 02139
Farmville, NC
Click here to add this to my saved trials
2590
mi
from 02139
Fresno, CA
Click here to add this to my saved trials
1774
mi
from 02139
Golden, CO
Click here to add this to my saved trials
2297
mi
from 02139
Goodyear, AZ
Click here to add this to my saved trials
Greenville, North Carolina 27834
574
mi
from 02139
Greenville, NC
Click here to add this to my saved trials
856
mi
from 02139
Gurnee, IL
Click here to add this to my saved trials
28
mi
from 02139
Haverhill, MA
Click here to add this to my saved trials
1601
mi
from 02139
Houston, TX
Click here to add this to my saved trials
802
mi
from 02139
Indianapolis, IN
Click here to add this to my saved trials
1047
mi
from 02139
Iowa City, IA
Click here to add this to my saved trials
1015
mi
from 02139
Jacksonville, FL
Click here to add this to my saved trials
1247
mi
from 02139
Kansas City, KS
Click here to add this to my saved trials
850
mi
from 02139
Kenosha, WI
Click here to add this to my saved trials
815
mi
from 02139
Knoxville, TN
Click here to add this to my saved trials
633
mi
from 02139
Marion, OH
Click here to add this to my saved trials
1254
mi
from 02139
Miami Beach, FL
Click here to add this to my saved trials
1117
mi
from 02139
Minneapolis, MN
Click here to add this to my saved trials
1333
mi
from 02139
Monroe, LA
Click here to add this to my saved trials
469
mi
from 02139
Norfolk, VA
Click here to add this to my saved trials
2090
mi
from 02139
Orem, UT
Click here to add this to my saved trials
268
mi
from 02139
Philadelphia, PA
Click here to add this to my saved trials
608
mi
from 02139
Raleigh, NC
Click here to add this to my saved trials
469
mi
from 02139
Richmond, VA
Click here to add this to my saved trials
334
mi
from 02139
Rochester, NY
Click here to add this to my saved trials
1769
mi
from 02139
San Antonio, TX
Click here to add this to my saved trials
2097
mi
from 02139
South Jordan, UT
Click here to add this to my saved trials
2256
mi
from 02139
Spokane, WA
Click here to add this to my saved trials
1034
mi
from 02139
St. Louis, MO
Click here to add this to my saved trials
2493
mi
from 02139
Tacoma, WA
Click here to add this to my saved trials
1393
mi
from 02139
Tulsa, OK
Click here to add this to my saved trials
468
mi
from 02139
Virginia Beach, VA
Click here to add this to my saved trials
2604
mi
from 02139
West Hills, CA
Click here to add this to my saved trials
2552
mi
from 02139
Wildomar, CA
Click here to add this to my saved trials
586
mi
from 02139
Wilson, NC
Click here to add this to my saved trials
288
mi
from 02139
Wyomissing, PA
Click here to add this to my saved trials