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

NCT02695420 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2021-07-27

Study results available
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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

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

25 mg Omecamtiv Mecarbil

oral tablet

DRUG

Placebo

oral tablet

DRUG

37.5 mg Omecamtiv Mecarbil

oral tablet

DRUG

50 mg Omecamtiv Mecarbil

oral tablet

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-14
Primary Completion
2017-04-06
Completion
2017-05-08

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02695420 on ClinicalTrials.gov