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)
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 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 adults with chronic heart failure with reduced ejection fraction (HFrEF).
This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.
Key Inclusion Criteria:
Other Inclusion Criteria May apply
Key Exclusion Criteria:
Other Exclusion Criteria May apply
Wiloughby, Ohio 44094, United States
CABA, Buenos Aires C1119ACN, Argentina
CABA, Buenos Aires C1406BOA, Argentina
CABA, Buenos Aires C1407GTN, Argentina
CABA, Buenos Aires C1428ART, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires 1209, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1280AEB, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1426ABP, Argentina
Ramos Meija, Buenos Aires B1704ETD, Argentina
Bogota D.C., Colombia
Klatovy IV, 339 01, Czechia
Kolin III, 280 02, Czechia
Praha 5 - Smichov, 150 00, Czechia
Pribram VIII, 261 01, Czechia
Bad Neuheim, 61231, Germany
Markleeberg, 04416, Germany
Chaidari, Athens, 12462, Greece
Cona FE, 44124, Italy
Rozzano MI, 20089, Italy
Torrette Di Ancona, 60126, Italy
Vimercate MB, 20871, Italy
Ichinomiya-shi, Aichi-ken 491-8551, Japan
Nagakute-shi, Aichi-ken 480-1195, Japan
Seto-shi, Aichi-ken 489-8642, Japan
Asahi-shi, Chiba 289-2511, Japan
Funabashi-shi, Chiba 273-8588, Japan
Urayasu-shi, Chiba 279-0021, Japan
Kasuya-gun, Fukuoka 811-2316, Japan
Kitakyushu-shi, Fukuoka 802-0077, Japan
Kitakyushu-shi, Fukuoka 802-8555, Japan
Kitakyushu-shi, Fukuoka 805-8508, Japan
Koga-shi, Fukuoka 811-3195, Japan
Kurume-shi, Fukuoka 830-8577, Japan
Kurume-shi, Fukuoka 839-0863, Japan
Onga-gun, Fukuoka 807-0051, Japan
Ogaki-shi, Gifu 503-8502, Japan
Takasaki-shi, Gunma 370-0829, Japan
Fukuyama-shi, Hiroshima 721-8511, Japan
Kure-shi, Hiroshima 737-0023, Japan
Hakodate-shi, Hokkaido 041-8512, Japan
Amagasaki-shi, Hyōgo 660-8550, Japan
Himeji-shi, Hyōgo 670-0981, Japan
Kawanishi-shi, Hyōgo 666-0125, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Takarazuka-shi, Hyōgo 665-0873, Japan
Higashiibaraki-gun, Ibaraki 311-3193, Japan
Kahoku-gun, Ishikawa-ken 920-0293, Japan
Kawasaki-shi, Kanagawa 210-0852, Japan
Kawasaki-shi, Kanagawa 211-8533, Japan
Kawasaki-shi, Kanagawa 216-8511, Japan
Odawara-shi, Kanagawa 250-8558, Japan
Sagamihara-shi, Kanagawa 252-0392, Japan
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Nankoku-shi, Kochi 783-8505, Japan
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Ureshino-shi, Saga-ken 843-0301, Japan
Ageo-shi, Saitama 362-8588, Japan
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Kusatsu-shi, Shiga 525-8585, Japan
Sunto-gun, Shizuoka 411-8611, Japan
Akishima-shi, Tokyo 196-0003, Japan
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Chuo-ku, Tokyo 104-8560, Japan
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