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Study Complete
Sponsor ID
20120227

Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction

Sponsor ID
20120227
Clinicaltrials.gov ID
NCT02695420
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

- 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

Additional Study Details

Phase
Phase 2
Product
omecamtiv mecarbil
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
81
Additional Study Details

Protocol Summary

Primary Outcome Measures

Pharmacokinetics: Concentration Before Morning Dose (Cpredose)

Timeframe: Before morning dose on Week 2 (Day 15), Week 4 (Day 28), Week 12 (Day 84), Week 16 (Day 112)

Pharmacokinetics: Area Under the Curve Until 8 Hours After Morning Dose at Week 8 (AUC0-8)

Timeframe: 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 Outcome Measures

Change From Baseline at Week 16 in Systolic Ejection Time (SET)

Timeframe: Baseline, Week 16 (Day 112)

Locations

Location
Status
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Location
Research Site
Chikushino-shi, Fukuoka, Japan, 818-8516
Status
Recruiting
Location
Research Site
Asahi-shi, Chiba, Japan, 289-2511
Status
Recruiting
Location
Research Site
Kawanishi-shi, Hyogo, Japan, 666-0125
Status
Recruiting
Location
Research Site
Nagoya-shi, Aichi, Japan, 454-8509
Status
Recruiting
Location
Research Site
Osaka-shi, Osaka, Japan, 532-0003
Status
Recruiting
Location
Research Site
Kanazawa-shi, Ishikawa, Japan, 920-8650
Status
Recruiting
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Study Info
Age
20 - 85 Years
Condition
  • Heart Failure
    • Sex
    All
    Trial Dates
    Apr 2016 - Apr 2017
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    -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
    Exclusion Criteria:
    -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 -Total bilirubin (TBL) ≥ 2x upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3x ULN Other Exclusion Criteria may apply.