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
1314
mi
from
Hialeah, FL
Click here to add this to my saved trials
99-193 Aiea Heights Drive
'Aiea, Hawaii 96701
3719
mi
from
'Aiea, HI
Click here to add this to my saved trials
1227
mi
from
Abington, PA
Click here to add this to my saved trials
1306
mi
from
Albany, NY
Click here to add this to my saved trials
523
mi
from
Albuquerque, NM
Click here to add this to my saved trials
540
mi
from
Alexandria, LA
Click here to add this to my saved trials
Altamonte Springs, Florida 32701
1136
mi
from
Altamonte Springs, FL
Click here to add this to my saved trials
1055
mi
from
Altoona, PA
Click here to add this to my saved trials
283
mi
from
Amarillo, TX
Click here to add this to my saved trials
1157
mi
from
Anaheim, CA
Click here to add this to my saved trials
808
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Arlington Heights, Illinois 60004
601
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
858
mi
from
Asheville, NC
Click here to add this to my saved trials
844
mi
from
Athens, GA
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
932
mi
from
Augusta, GA
Click here to add this to my saved trials
402
mi
from
Aurora, CO
Click here to add this to my saved trials
1314
mi
from
Aventura, FL
Click here to add this to my saved trials
5746
mi
from
Bahia Blanca,
Click here to add this to my saved trials
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
1575
mi
from
Bangor, ME
Click here to add this to my saved trials
1109
mi
from
Bay Pines, FL
Click here to add this to my saved trials
Beverly Hills, California 90211
1175
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
1481
mi
from
Biddeford, ME
Click here to add this to my saved trials
683
mi
from
Birmingham, AL
Click here to add this to my saved trials
1444
mi
from
Boston, MA
Click here to add this to my saved trials
1292
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
1291
mi
from
Bronx, NY
Click here to add this to my saved trials
1287
mi
from
Brooklyn, NY
Click here to add this to my saved trials
1056
mi
from
Buffalo, NY
Click here to add this to my saved trials
1171
mi
from
Burbank, CA
Click here to add this to my saved trials
1356
mi
from
Burlington, VT
Click here to add this to my saved trials
978
mi
from
Butler, PA
Click here to add this to my saved trials
1227
mi
from
Camden, NJ
Click here to add this to my saved trials
1132
mi
from
Camp Hill, PA
Click here to add this to my saved trials
1274
mi
from
Carmichael, CA
Click here to add this to my saved trials
334
mi
from
Carrollton, TX
Click here to add this to my saved trials
1060
mi
from
Cary, NC
Click here to add this to my saved trials
539
mi
from
Champaign, IL
Click here to add this to my saved trials
1043
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29412
1064
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
959
mi
from
Charlotte, NC
Click here to add this to my saved trials
1053
mi
from
Charlottesville, VA
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
726
mi
from
Cincinnati, OH
Click here to add this to my saved trials
895
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
383
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
1134
mi
from
Columbia, MD
Click here to add this to my saved trials
310
mi
from
Columbia, MO
Click here to add this to my saved trials
811
mi
from
Columbus, GA
Click here to add this to my saved trials
810
mi
from
Columbus, OH
Click here to add this to my saved trials
Cortlandt Manor, New York 10567
1294
mi
from
Cortlandt Manor, NY
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
721
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
1069
mi
from
Crystal River, FL
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
746
mi
from
Dayton, OH
Click here to add this to my saved trials
1128
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
285
mi
from
Denison, TX
Click here to add this to my saved trials
409
mi
from
Denver, CO
Click here to add this to my saved trials
346
mi
from
Des Moines, IA
Click here to add this to my saved trials
841
mi
from
Detroit, MI
Click here to add this to my saved trials
1314
mi
from
Doral, FL
Click here to add this to my saved trials
1051
mi
from
Durham, NC
Click here to add this to my saved trials
1283
mi
from
Eatontown, NJ
Click here to add this to my saved trials
641
mi
from
El Paso, TX
Click here to add this to my saved trials
983
mi
from
Erie, PA
Click here to add this to my saved trials
125 Saint Clair Square
Fairview Heights, Illinois 62208
429
mi
from
Fairview Heights, IL
Click here to add this to my saved trials
784
mi
from
Farmington, UT
Click here to add this to my saved trials
Fort Mill, South Carolina 29707
956
mi
from
Fort Mill, SC
Click here to add this to my saved trials
712
mi
from
Fort Payne, AL
Click here to add this to my saved trials
574
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
346
mi
from
Fort Worth, TX
Click here to add this to my saved trials
1210
mi
from
Fresno, CA
Click here to add this to my saved trials
1047
mi
from
Gainesville, FL
Click here to add this to my saved trials
609
mi
from
Galveston, TX
Click here to add this to my saved trials
481
mi
from
Germantown, TN
Click here to add this to my saved trials
838
mi
from
Gilbert, AZ
Click here to add this to my saved trials
570
mi
from
Gonzales, TX
Click here to add this to my saved trials
826
mi
from
Grand Blanc, MI
Click here to add this to my saved trials
689
mi
from
Green Bay, WI
Click here to add this to my saved trials
Greensboro, North Carolina 27401
1002
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
882
mi
from
Greenville, SC
Click here to add this to my saved trials
1089
mi
from
Hagerstown, MD
Click here to add this to my saved trials
1358
mi
from
Hartford, CT
Click here to add this to my saved trials
1445
mi
from
Haverhill, MA
Click here to add this to my saved trials
600
mi
from
Hazel Crest, IL
Click here to add this to my saved trials
1147
mi
from
Hershey, PA
Click here to add this to my saved trials
921
mi
from
Hickory, NC
Click here to add this to my saved trials
3718
mi
from
Honolulu, HI
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington, West Virginia 25701
836
mi
from
Huntington, WV
Click here to add this to my saved trials
Huntington Beach, California 92646
1162
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
660
mi
from
Huntsville, AL
Click here to add this to my saved trials
656
mi
from
Huntsville, TX
Click here to add this to my saved trials
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
1084
mi
from
Inverness, FL
Click here to add this to my saved trials
429
mi
from
Iowa City, IA
Click here to add this to my saved trials
518
mi
from
Jackson, TN
Click here to add this to my saved trials
1053
mi
from
Jacksonville, FL
Click here to add this to my saved trials
307
mi
from
Jefferson City, MO
Click here to add this to my saved trials
Jersey Shore, Pennsylvania 17740
1119
mi
from
Jersey Shore, PA
Click here to add this to my saved trials