Phase 2
Completed N=81
Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction
Source: ClinicalTrials.gov NCT02695420 ↗Enrolled (actual)
81
Serious AEs
13.6%
Results posted
Jan 2020
Primary outcomePrimary: Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time — 239; 179; 208; 222 ng/mL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time |
239; 179; 208; 222; 196; 209 | — |
| PRIMARY PK: Area Under the Curve Until 8 Hours After Morning Dose at Week 8 (AUC0-8) |
1850; 1850; 2360 | — |
| SECONDARY Change From Baseline at Week 16 in Systolic Ejection Time (SET) |
-1.7; 20.5; 27.6; 23.8 | 0.0008 sig |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT02695420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.