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

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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
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