01 September 2023 | Friday | News
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The three additional studies are sponsored by CPC Clinical Research, a non-profit academic research organization affiliated with University of Colorado, which is conducting the studies in collaboration with other academic research organizations. The program is funded by Bayer. 2,3,4
In addition to the ongoing Phase III study FINEARTS-HF, investigating finerenone versus placebo on top of standard of care (SoC) in more than 6,000 HF patients with mildly reduced or preserved ejection fraction,1 the new studies will evaluate the efficacy and safety of finerenone in approximately 9,000 additional HF patients with reduced (HfrEF), mildly reduced (HfmrEF), and/or preserved ejection fraction (HfpEF).2,3,4
“With the addition of the REDEFINE-HF, CONFIRMATION-HF and FINALITY-HF studies to the MOONRAKER heart failure clinical trial program, we aim to gain a comprehensive understanding of the potential of finerenone for the treatment of heart failure, examining its efficacy and safety across a broad spectrum of patients and clinical settings,” said Dr. Michael Devoy, Chief Medical Officer, Bayer. “The studies will complement our Phase III FINEARTS-HF study, and we hope the findings will provide additional guidance around the potential clinical implementation of finerenone.”
“Bayer is determined to drive research and innovations for patients that have the potential to expand treatment options in diseases of high unmet medical need,” said Robert Perkins, MD, Vice President, Cardiovascular & Renal, Bayer. “The newly added trials under MOONRAKER are designed to rigorously address common, important clinical scenarios for patients living with heart failure. Simply put—more needs to be done, and quickly. We are working to answer that call.”
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