Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction
1 other identifier
interventional
81
1 country
32
Brief Summary
- To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart failure (HF) with reduced ejection fraction
- To evaluate the safety and tolerability of oral omecamtiv mecarbil
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2016
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 1, 2016
CompletedStudy Start
First participant enrolled
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2017
CompletedResults Posted
Study results publicly available
January 31, 2020
CompletedJuly 27, 2021
July 1, 2021
12 months
February 25, 2016
January 23, 2020
July 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time
Before morning dose on Week 2 (Day 15), Week 4 (Day 28), Week 12 (Day 84), Week 16 (Day 112)
PK: Area Under the Curve Until 8 Hours After Morning Dose at Week 8 (AUC0-8)
Week 8 (Day 56) at predose, at 2 hours ±30 minutes; 4 hours ±30 minutes; 6 hours ±30 minutes; 8 hours ±30 minutes after morning dose
Secondary Outcomes (1)
Change From Baseline at Week 16 in Systolic Ejection Time (SET)
Baseline, Week 16 (Day 112)
Other Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
From first dose of study drug up to Week 20 (Day 140 + 3 days)
Study Arms (4)
Placebo BID
PLACEBO COMPARATORParticipants will receive placebo BID.
25 mg Omecamtiv Mecarbil BID
EXPERIMENTALParticipants will receive 25 mg omecamtiv mecarbil BID.
37.5 mg Omecamtiv Mecarbil BID Target Dose
EXPERIMENTALParticipants 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.
50 mg Omecamtiv Mecarbil BID Target Dose
EXPERIMENTALParticipants 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.
Interventions
oral tablet
Eligibility Criteria
You may qualify if:
- Japanese male or female ≥ 20 years and ≤ 85 years of age
- 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
You may not qualify if:
- Severe uncorrected valvular heart disease
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cytokineticslead
Study Sites (32)
Research Site
Kasugai-shi, Aichi-ken, 486-8510, Japan
Research Site
Kasugai-shi, Aichi-ken, 487-0016, Japan
Research Site
Nagoya, Aichi-ken, 454-8509, Japan
Research Site
Asahi-shi, Chiba, 289-2511, Japan
Research Site
Chiba, Chiba, 260-8606, Japan
Research Site
Imabari, Ehime, 799-1592, Japan
Research Site
Chikushino-shi, Fukuoka, 818-8516, Japan
Research Site
Fukuoka, Fukuoka, 814-0180, Japan
Research Site
Fukuoka, Fukuoka, 815-8588, Japan
Research Site
Hakodate-shi, Hokkaido, 041-8512, Japan
Research Site
Sapporo, Hokkaido, 060-8648, Japan
Research Site
Amagasaki-shi, Hyōgo, 660-8550, Japan
Research Site
Kawanishi-shi, Hyōgo, 666-0125, Japan
Research Site
Takarazuka-shi, Hyōgo, 665-0873, Japan
Research Site
Kanazawa, Ishikawa-ken, 920-8650, Japan
Research Site
Nankoku-shi, Kochi, 783-8505, Japan
Research Site
Ōita, Oita Prefecture, 870-0192, Japan
Research Site
Okayama, Okayama-ken, 702-8055, Japan
Research Site
Kishiwada-shi, Osaka, 596-8522, Japan
Research Site
Osaka, Osaka, 532-0003, Japan
Research Site
Osaka, Osaka, 550-0012, Japan
Research Site
Osaka, Osaka, 559-0012, Japan
Research Site
Suita-shi, Osaka, 565-0871, Japan
Research Site
Saga, Saga-ken, 840-8571, Japan
Research Site
Saitama-shi, Saitama, 330-8503, Japan
Research Site
Wako-shi, Saitama, 351-0102, Japan
Research Site
Sunto-gun, Shizuoka, 411-8611, Japan
Research Site
Chiyoda-ku, Tokyo, 101-8309, Japan
Research Site
Itabashi-ku, Tokyo, 173-0015, Japan
Research Site
Itabashi-ku, Tokyo, 173-8610, Japan
Research Site
Meguro-ku, Tokyo, 152-8902, Japan
Research Site
Shinagawa-ku, Tokyo, 141-0001, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2016
First Posted
March 1, 2016
Study Start
April 14, 2016
Primary Completion
April 6, 2017
Study Completion
May 8, 2017
Last Updated
July 27, 2021
Results First Posted
January 31, 2020
Record last verified: 2021-07