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Data Monitoring Committee recommends phase III clinical trial of omecamtiv mecarbil in patients with Heart failure continue without changes.-Amgen + Cytokinetic s+ Servier.

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Published:27th Feb 2020
Amgen, Cytokinetics, and Servier announced that the Data Monitoring Committee (DMC) for GALACTIC-HF recently completed the second and final planned interim analysis, which included consideration of pre-specified criteria for futility and superiority. The DMC reviewed data from GALACTIC-HF and recommended that this Phase III clinical trial of omecamtiv mecarbil continue without changes to its conduct. The second interim analysis was triggered once a pre-specified number of cardiovascular deaths had occurred in GALACTIC-HF as stipulated by the trial's protocol. A futility analysis allowed the potential for stopping GALACTIC-HF early had the interim analysis shown a low likelihood of the trial demonstrating a clinically meaningful and statistically significant benefit on the primary endpoint in patients receiving omecamtiv mecarbil, plus standard of care, compared to patients receiving placebo plus standard of care. A superiority analysis allowed the potential for stopping the trial early if the primary composite endpoint and the secondary endpoint (time to cardiovascular death) reached statistical significance, adjusting the statistical threshold for interim review. The DMC considers all available evidence in its recommendations regarding trial conduct, and the stopping boundaries provide guidance to the DMC but are not binding rules. GALACTIC-HF, one of the largest Phase III global cardiovascular outcomes studies in heart failure ever conducted, has now completed enrollment of more than 8,200 patients in 35 countries who were either hospitalized at the time of enrollment for a primary reason of heart failure, or had a hospitalization or admission to an emergency room for heart failure within one year prior to screening. It is designed to evaluate whether treatment with omecamtiv mecarbil, when added to standard of care, reduces the risk of heart failure events (heart failure hospitalization and other urgent treatment for heart failure) and CV death in patients with heart failure with reduced ejection fraction (HFrEF). Comment: Topline Results Expected in Q4 2020.
Condition: Heart Failure
Type: drug

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