CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 544 enrolled
Drug / intervention
Omecamtiv Mecarbil Matrix F1 Formulation +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01786512
NCT01786512Phase 2Completed
CompareCT.gov

A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose Escalation Study to Select and Evaluate an Oral Modified Release Formulation of Omecamtiv Mecarbil in Subjects With Heart Failure and Left Ventricular Systolic Dysfunction

Cytokinetics·interventional·Posted Feb 8, 2013·Updated Aug 12, 2021

In Brief

A Phase 2 clinical trial evaluating Omecamtiv Mecarbil Matrix F1 Formulation, Omecamtiv Mecarbil Matrix F2 Formulation, and 2 other interventions for Modified Release Oral Formulation and 6 related conditions. Completed, enrolled 544 participants across 101 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModified Release Oral Formulation, Left Ventricular Systolic Dysfunction, Chronic Heart Failure, History of Chronic Heart Failure, Left Ventricular Ejection Fraction, Pharmacokinetics, Echocardiogram
CountriesAustralia, Belgium, Bulgaria, Canada, Czechia, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2013
Enrollment StartFeb 26, 2013
Primary CompletionJul 22, 2015
Study CompletionAug 19, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.4 years ago

Interventions

Omecamtiv Mecarbil Matrix F1 Formulationdrug

Modified release tablets for oral administration

Omecamtiv Mecarbil Matrix F2 Formulationdrug

Modified release tablets for oral administration

Placebodrug

Modified release tablets matching to omecamtiv mecarbil

Omecamtiv Mecarbil Swellable Core Technology F2drug

Modified release tablets for oral administration