circle

Over 50 clinical trials with a single focus:Improve lives

Clinical Trials

GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) –GALACTIC-HF was a Phase 3, double-blind, placebo-controlled, multicenter clinical trial conducted by Amgen in collaboration with Cytokinetics, and one of the largest Phase 3 global cardiovascular outcomes studies in heart failure ever conducted. The trial evaluated the effect of treatment with omecamtiv mecarbil compared with placebo in approximately 8,256 patients with chronic heart failure with reduced ejection fraction (HFrEF) who were at risk of hospitalization and death, despite being well treated on standard of care therapy. After a median duration of follow-up of 21.8 months, the trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care (hazard ratio, 0.92; 95% confidence interval, 0.89 to 0.99; p=0.0252). No reduction in the secondary endpoint of time to CV death was observed. Adverse events, including major ischemic cardiac events, were balanced between the treatment arms. These results were published in NEJM, available online here.

 

A secondary analysis from GALACTIC-HF of ejection fraction as a continuous variable demonstrated a progressively larger treatment effect of omecamtiv mecarbil with decreasing ejection fraction (interaction p = 0.013 by EF quartile). For more information about this trial, click here.
METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure) – METEORIC-HF is a Phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. This trial is designed to enroll approximately 270 patients with HFrEF at sites throughout the U.S., Canada and Europe. For more information about this trial, click here.
COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) – Cytokinetics and Amgen announced results from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating oral omecamtiv mecarbil in patients with chronic heart failure and left ventricular systolic dysfunction, at the American Heart Association Scientific Sessions in November 2015. COSMIC-HF was a double-blind, randomized, placebo-controlled, multicenter, dose escalation study designed to evaluate the pharmacokinetics and tolerability of orally-administered omecamtiv mecarbil in approximately 450 patients.
ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) – Cytokinetics and Amgen announced results from ATOMIC-AHF (A Trial of Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure), a Phase 2b trial evaluating omecamtiv mecarbil in acutely ill, hospitalized heart failure patients, at the European Society of Cardiology (ESC) Congress and the Heart Failure Society of America (HFSA) Annual Meeting, both in September 2013. This clinical trial was an international, multicenter, randomized, double-blind, placebo-controlled study in approximately 600 patients, enrolled in three sequential, ascending-dose cohorts. In each cohort, patients were randomized to receive omecamtiv mecarbil or placebo.
REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) – REDWOOD-HCM is a multi-center, randomized, placebo-controlled, double-blind, dose-finding clinical trial in patients with symptomatic, obstructive HCM (oHCM). The primary objective of the trial is to determine the safety and tolerability of CK-274. The secondary objectives are to describe the concentration-response and dose-response relationship of CK-274 on the resting and post-Valsalva left ventricular outflow tract gradient as measured by echocardiography during 10 weeks of treatment. Additionally, the trial will evaluate the plasma concentrations of CK-274 in patients with oHCM in relationship to dose. Exploratory objectives include the effect of CK-274 on N‑terminal prohormone of brain natriuretic peptide (NT‑proBNP) and New York Heart Association (NYHA) Functional Classification. REDWOOD-HCM has completed enrollment in Cohort 1 and Cohort 2, two sequential cohorts in which approximately 20 patients were randomized 2:1 in each cohort to active or placebo treatment and received up to three escalating doses of CK-274 or placebo based on echocardiographic guidance. Cohort 3 is enrolling patients whose background therapy includes disopyramide. For more information about the trial, click here.
FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints in ALS) – Cytokinetics announced results from FORTITUDE-ALS, a Phase 2, double-blind, randomized, dose-ranging, placebo-controlled, parallel group study of reldesemtiv in patients with ALS at the American Academy of Neurology meeting in May 2019. The trial enrolled 458 patients with ALS in the US, Canada, Europe and Australia. The trial did not achieve statistical significance for its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing, but all patients on all doses of reldesemtiv declined less than patients on placebo for SVC and ALSFRS-R, with clinically meaningful differences emerging over time. For more information about the trial, click here.