Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Omecamtiv Mecarbil for Exercise Capacity in HFrEF
NCT03759392Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2019
- Primary completion
- Nov 2021
- Countries
- 9
- Sponsor
- Cytokinetics
- Modality
- Small Molecules
- Drugs
- omecamtiv mecarbil
- Conditions
- heart failure with reduced ejection fraction (HFrEF)
01
Overview
Phase 3, randomised, double-blind trial in heart failure with reduced ejection fraction (HFrEF) comparing Omecamtiv Mecarbil with Placebo (2 arms). Primary endpoint: Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing at 20 weeks. Started Apr 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Omecamtiv Mecarbil
Omecamtiv mecarbil + Standard of Care
Placebo
Placebo + Standard of Care
03
Who it enrols
Patients with chronic HFrEF (LVEF <= 35%, NYHA II-III) on stable standard of care, with elevated NT-proBNP and reduced exercise capacity (Peak VO2 <= 75% predicted).
04
Endpoints
Primary
Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing
Secondary
Change in Total Workload During Cardiopulmonary Exercise Testing
Change in Ventilatory Efficiency During Cardiopulmonary Exercise Testing
Change in Average Daily Activity Units
05
Results
Not all primary endpoints met
Beyond the preview
Go deeper on NCT03759392.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03759392.