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COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure

NCT01786512 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2021-08-12

Study results available
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Summary

The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults with heart failure and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) over 20 weeks of treatment.

Conditions

  • Modified Release Oral Formulation
  • Left Ventricular Systolic Dysfunction
  • Chronic Heart Failure
  • History of Chronic Heart Failure
  • Left Ventricular Ejection Fraction
  • Pharmacokinetics
  • Echocardiogram

Interventions

DRUG

Omecamtiv Mecarbil Matrix F1 Formulation

Modified release tablets for oral administration

DRUG

Omecamtiv Mecarbil Matrix F2 Formulation

Modified release tablets for oral administration

DRUG

Placebo

Modified release tablets matching to omecamtiv mecarbil

DRUG

Omecamtiv Mecarbil Swellable Core Technology F2

Modified release tablets for oral administration

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-02-26
Primary Completion
2015-07-22
Completion
2015-08-19

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01786512 on ClinicalTrials.gov