Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction
NCT ID: NCT02695420
Last Updated: 2021-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2016-04-14
2017-05-08
Brief Summary
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* To evaluate the safety and tolerability of oral omecamtiv mecarbil
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo BID
Participants will receive placebo BID.
25 mg Omecamtiv Mecarbil
oral tablet
25 mg Omecamtiv Mecarbil BID
Participants will receive 25 mg omecamtiv mecarbil BID.
Placebo
oral tablet
37.5 mg Omecamtiv Mecarbil BID Target Dose
Participants will receive omecamtiv mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 37.5 mg BID after Week 4 or Week 8, based on Week 2 PK.
25 mg Omecamtiv Mecarbil
oral tablet
37.5 mg Omecamtiv Mecarbil
oral tablet
50 mg Omecamtiv Mecarbil BID Target Dose
Participants will receive Omecamtiv Mecarbil 25 mg BID up to Week 4 or Week 8 and 25 mg or 50 mg BID after Week 4 or Week 8, based on Week 2 PK.
25 mg Omecamtiv Mecarbil
oral tablet
50 mg Omecamtiv Mecarbil
oral tablet
Interventions
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25 mg Omecamtiv Mecarbil
oral tablet
Placebo
oral tablet
37.5 mg Omecamtiv Mecarbil
oral tablet
50 mg Omecamtiv Mecarbil
oral tablet
Eligibility Criteria
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Inclusion Criteria
* History of chronic stable heart failure (HF) with reduced ejection fraction, defined as requiring treatment for HF for a minimum of 4 weeks prior to screening
* Treated for HF with optimal pharmacological therapy
* Left ventricular ejection fraction ≤ 40% at screening
Exclusion Criteria
* Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
* Acute myocardial infarction, unstable angina, or persistent angina at rest within 30 days prior to randomization
* Systolic blood pressure (BP) \> 160 mmHg or \< 90 mmHg, or diastolic BP \> 90 mmHg, or heart rate (HR) \> 110 beats per minute (bpm) or HR \< 50 bpm
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2
20 Years
85 Years
ALL
No
Sponsors
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Cytokinetics
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Kasugai-shi, Aichi-ken, Japan
Research Site
Kasugai-shi, Aichi-ken, Japan
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Asahi-shi, Chiba, Japan
Research Site
Chiba, Chiba, Japan
Research Site
Imabari, Ehime, Japan
Research Site
Chikushino-shi, Fukuoka, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Hakodate-shi, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Amagasaki-shi, Hyōgo, Japan
Research Site
Kawanishi-shi, Hyōgo, Japan
Research Site
Takarazuka-shi, Hyōgo, Japan
Research Site
Kanazawa, Ishikawa-ken, Japan
Research Site
Nankoku-shi, Kochi, Japan
Research Site
Ōita, Oita Prefecture, Japan
Research Site
Okayama, Okayama-ken, Japan
Research Site
Kishiwada-shi, Osaka, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Suita-shi, Osaka, Japan
Research Site
Saga, Saga-ken, Japan
Research Site
Saitama-shi, Saitama, Japan
Research Site
Wako-shi, Saitama, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Chiyoda-ku, Tokyo, Japan
Research Site
Itabashi-ku, Tokyo, Japan
Research Site
Itabashi-ku, Tokyo, Japan
Research Site
Meguro-ku, Tokyo, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20120227
Identifier Type: -
Identifier Source: org_study_id
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