Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:4/6/2019
Start Date:January 6, 2017
End Date:January 27, 2021
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when
added to standard of care is well tolerated and superior to placebo in reducing the risk of
cardiovascular death or heart failure events in subjects with chronic HFrEF.


Key Inclusion Criteria:

- Subject has provided informed consent

- Male or female, ≥ 18 to ≤ 85 years

- History of chronic HF (defined as requiring treatment for HF for a minimum of 30 days
before randomization)

- LVEF ≤ 35%, per subjects most recent medical record, within 12 months prior to
screening.

- NYHA class II to IV at most recent screening assessment.

- Managed with HF SoC therapies consistent with regional clinical practice guidelines
according to investigator judgment of subject's clinical status

- Current hospitalization with primary reason of HF OR one of the following events
within 1 year of screening: hospitalization with primary reason of HF; urgent visit to
emergency department (ED) with primary reason of HF.

- Elevated BNP or NT-proBNP

Other Inclusion Criteria May apply

Key Exclusion Criteria:

- Currently receiving treatment in another investigational device or drug study, or < 30
days since ending treatment on another investigational device or drug study(ies).
Other investigational procedures while participating in this study are excluded.

- Malignancy within 5 years prior to randomization with the following exceptions:
localized basal or squamous cell carcinoma of the skin, cervical intraepithelial
neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.

- Subject has known sensitivity to any of the products or components to be administered
during testing

Other Exclusion Criteria May apply
We found this trial at
254
sites
?
mi
from
Midland, MI
Click here to add this to my saved trials
99-193 Aiea Heights Drive
'Aiea, Hawaii 96701
?
mi
from
'Aiea, HI
Click here to add this to my saved trials
?
mi
from
Abington, PA
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Altamonte Springs, Florida 32701
?
mi
from
Altamonte Springs, FL
Click here to add this to my saved trials
?
mi
from
Altoona, PA
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Arlington Heights, Illinois 60004
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Athens, GA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
?
mi
from
Bahia Blanca,
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bangor, ME
Click here to add this to my saved trials
?
mi
from
Bay Pines, 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
?
mi
from
Biddeford, ME
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
?
mi
from
Burbank, CA
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Butler, PA
Click here to add this to my saved trials
?
mi
from
Camden, NJ
Click here to add this to my saved trials
?
mi
from
Camp Hill, PA
Click here to add this to my saved trials
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
?
mi
from
Cary, NC
Click here to add this to my saved trials
?
mi
from
Champaign, IL
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbia, MD
Click here to add this to my saved trials
?
mi
from
Columbia, MO
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Cortlandt Manor, New York 10567
?
mi
from
Cortlandt Manor, NY
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
?
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
?
mi
from
Crystal River, FL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
?
mi
from
Denison, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Doral, FL
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
?
mi
from
Erie, PA
Click here to add this to my saved trials
125 Saint Clair Square
Fairview Heights, Illinois 62208
?
mi
from
Fairview Heights, IL
Click here to add this to my saved trials
?
mi
from
Farmington, UT
Click here to add this to my saved trials
Fort Mill, South Carolina 29707
?
mi
from
Fort Mill, SC
Click here to add this to my saved trials
?
mi
from
Fort Payne, AL
Click here to add this to my saved trials
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Galveston, TX
Click here to add this to my saved trials
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
?
mi
from
Gonzales, TX
Click here to add this to my saved trials
?
mi
from
Grand Blanc, MI
Click here to add this to my saved trials
?
mi
from
Green Bay, WI
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 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
?
mi
from
Hartford, CT
Click here to add this to my saved trials
?
mi
from
Haverhill, MA
Click here to add this to my saved trials
?
mi
from
Hazel Crest, IL
Click here to add this to my saved trials
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hickory, NC
Click here to add this to my saved trials
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington, West Virginia 25701
?
mi
from
Huntington, WV
Click here to add this to my saved trials
Huntington Beach, California 92646
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Huntsville, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Inverness, FL
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Jackson, TN
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jefferson City, MO
Click here to add this to my saved trials