Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C



Status:Not yet recruiting
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/25/2019
Start Date:August 2019
End Date:December 2023
Contact:The Medicines Company Global Health Science Center
Email:medical.information@themedco.com
Phone:1-888-977-6326

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

An Open-label Extension Trial of the Phase III Lipid-lowering Trials to Assess the Effect of Long Term Dosing of Inclisiran Given as Subcutaneous Injections in Subjects With High Cardiovascular Risk and Elevated LDL-C

The purpose of this extension study is to evaluate the efficacy, safety, and tolerability of
long-term dosing of Inclisiran. The study will be a global multicenter study.

This study will be an open label, long term extension study in subjects with atherosclerotic
cardiovascular disease (ASCVD), ASCVD-risk equivalents (eg, diabetes and familial
hypercholesterolemia), or heterozygous or homozygous familial hypercholesterolemia (HeFH or
HoFH) and elevated low density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose
of LDL-C lowering therapies who have completed any of the following inclisiran Phase III
lipid lowering studies: MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-04 (ORION-10), MDCO-PCS-17-08
(ORION-11) or MDCO-PCS-17-02 (ORION-5).

Inclusion Criteria:

1. Completion of a previously qualifying Phase III lipid-lowering ORION feeder study
[MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-04 (ORION-10), MDCO-PCS-17-08 (ORION-11) or
MDCO-PCS-17-02 (ORION-5)] meaning the subject received the last dose of study drug and
completed the final study visit per applicable protocol.

2. On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previous
study with no planned medication or dose change during study participation.

3. Willing and able to give informed consent before initiation of any study-related
procedures and willing to comply with all required study procedures.

Exclusion Criteria:

1. Any uncontrolled or serious disease, or any medical or surgical condition, that may
either interfere with participation in the clinical study, and/or put the subject at
significant risk [according to investigator's (or delegate's) judgment] if he/she
participates in the clinical study.

2. An underlying known disease, or surgical, physical, or medical condition that, in the
opinion of the investigator (or delegate) might interfere with interpretation of the
clinical study results.

3. Severe concomitant noncardiovascular disease that carries the risk of reducing life
expectancy to less than 3 years,

4. Active liver disease defined as any known current infectious, neoplastic, or metabolic
pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate
aminotransferase (AST), elevation >3x the upper limit of normal (ULN), or total
bilirubin (TBIL) elevation >2x ULN at the last recorded visit in the feeder study
prior to study entry visit.

5. Females who are pregnant or nursing, or who are of childbearing potential and
unwilling to use at least one method of acceptable effective contraception (eg, oral
contraceptives, barrier methods, approved contraceptive implant, long-term injectable
contraception, intrauterine device) for the entire duration of the study. Exemptions
from this criterion:

1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual
period) and more than 55 years of age.

2. Postmenopausal women (as defined above) and less than 55 years of age with a
negative pregnancy test within 24 hours of randomization.

3. Women who are surgically sterilized at least 3 months prior to enrollment.

6. Planned use of other investigational medicinal products other than inclisiran or
devices during the course of the study.

7. Any condition that according to the investigator could interfere with the conduct of
the study, such as but not limited to:

1. Subjects who are unable to communicate or to cooperate with the investigator

2. Unable to understand the protocol requirements, instructions and study-related
restrictions, the nature, scope, and possible consequences of the study
(including subjects whose cooperation is doubtful due to drug abuse or alcohol
dependency)

3. Unlikely to comply with the protocol requirements, instructions, and
study-related restrictions (eg, uncooperative attitude, inability to return for
follow-up visits, and improbability of completing the study)

4. Have any medical or surgical condition, which in the opinion of the investigator
would put the subject at increased risk from participating in the study

5. Persons directly involved in the conduct of the study.

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
118
sites
Binghamton, New York 13901
?
mi
from
Binghamton, NY
Click here to add this to my saved trials
Akron, Ohio 44331
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
Amarillo, Texas 79106
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Athens, Tennessee 37303
?
mi
from
Athens, TN
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
13729 Research Boulevard
Austin, Texas 78758
?
mi
from
Austin, TX
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
Birmingham, Alabama 35211
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boca Raton, Florida 33434
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Bridgewater, New Jersey 08807
?
mi
from
Bridgewater, NJ
Click here to add this to my saved trials
Calhoun, Georgia 30701
?
mi
from
Calhoun, GA
Click here to add this to my saved trials
Canoga Park, California 91303
?
mi
from
Canoga Park, CA
Click here to add this to my saved trials
Carlsbad, California 92008
?
mi
from
Carlsbad, CA
Click here to add this to my saved trials
Cary, North Carolina 27518
?
mi
from
Cary, NC
Click here to add this to my saved trials
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chicago, Illinois 60616
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Columbus, Ohio 43212
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Crowley, Louisiana 70526
?
mi
from
Crowley, LA
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dayton, Ohio 45419
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Daytona Beach, Florida 32117
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
Decatur, Georgia 30030
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Dunwoody, Georgia 30338
?
mi
from
Dunwoody, GA
Click here to add this to my saved trials
Edina, Minnesota 55435
?
mi
from
Edina, MN
Click here to add this to my saved trials
Edinburg, Texas 78503
?
mi
from
Edinburg, TX
Click here to add this to my saved trials
Edmond, Oklahoma 73003
?
mi
from
Edmond, OK
Click here to add this to my saved trials
El Cajon, California 92020
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
Endwell, New York 13760
?
mi
from
Endwell, NY
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Falls Church, Virginia 22042
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Fleming Island, Florida 32003
?
mi
from
Fleming Island, FL
Click here to add this to my saved trials
Flint, Michigan 48504
?
mi
from
Flint, MI
Click here to add this to my saved trials
Foley, Alabama 36535
?
mi
from
Foley, AL
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Worth, Texas 76106
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Grandville, Michigan 49418
?
mi
from
Grandville, MI
Click here to add this to my saved trials
Greeneville, Tennessee 37745
?
mi
from
Greeneville, TN
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77090
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Hutchinson, Kansas 67502
?
mi
from
Hutchinson, KS
Click here to add this to my saved trials
Indianapolis, Indiana 46254
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32204
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
105 West Stone Drive
Kingsport, Tennessee 37660
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
Knoxville, Tennessee 37909
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Las Vegas, Nevada 89123
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Layton, Utah 84041
?
mi
from
Layton, UT
Click here to add this to my saved trials
Lexington, Kentucky 40503
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Lubbock, Texas 79410
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
Macon, Georgia 31210
?
mi
from
Macon, GA
Click here to add this to my saved trials
Manassas, Virginia 20110
?
mi
from
Manassas, VA
Click here to add this to my saved trials
Marion, Ohio 43302
?
mi
from
Marion, OH
Click here to add this to my saved trials
Mesa, Arizona 85213
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Miami, Florida 33156
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Springs, Florida 33166
?
mi
from
Miami Springs, FL
Click here to add this to my saved trials
Midlothian, Virginia 23114
?
mi
from
Midlothian, VA
Click here to add this to my saved trials
Minneapolis, Minnesota 55416
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mobile, Alabama 36608
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Monroe, Louisiana 71201
?
mi
from
Monroe, LA
Click here to add this to my saved trials
Montgomery, Alabama 36117
?
mi
from
Montgomery, AL
Click here to add this to my saved trials
Mooresville, North Carolina 28117
?
mi
from
Mooresville, NC
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29588
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
New Braunfels, Texas 78130
?
mi
from
New Braunfels, TX
Click here to add this to my saved trials
New Windsor, New York 12553
?
mi
from
New Windsor, NY
Click here to add this to my saved trials
Northridge, California 91324
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Omaha, Nebraska 68131
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Owensboro, Kentucky 42303
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
Pelzer, South Carolina 29669
?
mi
from
Pelzer, SC
Click here to add this to my saved trials
Pembroke Pines, Florida 33024
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Phoenix, Arizona 85014
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pinellas Park, Florida 33781
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Ponte Vedra, Florida 32081
?
mi
from
Ponte Vedra, FL
Click here to add this to my saved trials
Poughkeepsie, New York 12601
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
Rapid City, South Dakota 57701
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Richmond, Virginia 23294
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Round Rock, Texas 78681
?
mi
from
Round Rock, TX
Click here to add this to my saved trials
3750 Auburn Boulevard
Sacramento, California 95821
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Augustine, Florida 32086
?
mi
from
Saint Augustine, FL
Click here to add this to my saved trials
41 1st Avenue
Saint Louis, Missouri 63136
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Paul, Minnesota 55102
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
436 State Capitol
Salt Lake City, Utah 84101
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Ramon, California 94582
?
mi
from
San Ramon, CA
Click here to add this to my saved trials
2301 Hardies Lane
Santa Rosa, California 95403
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Saraland, Alabama 36571
?
mi
from
Saraland, AL
Click here to add this to my saved trials
Sarasota, Florida 34239
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Schertz, Texas 78154
?
mi
from
Schertz, TX
Click here to add this to my saved trials
Sellersburg, Indiana 47172
?
mi
from
Sellersburg, IN
Click here to add this to my saved trials
Shavano Park, Texas 78231
?
mi
from
Shavano Park, TX
Click here to add this to my saved trials