Kowa Achieves Goal Of Randomizing 10,000 Patients Into Landmark "PROMINENT" Cardiovascular Outcomes Study Of K-877 (Pemafibrate)
RESEARCH TRIANGLE PARK, N.C., Feb. 19, 2020 /PRNewswire/ -- Kowa Research Institute, Inc., announced the achievement of its goal to randomize 10,000 subjects into its international, multi-center Phase 3 cardiovascular outcomes trial titled "Pemafibrate to Reduce cardiovascular OutcoMes by reducing triglycerides IN patiENts with diabeTes" (PROMINENT). The trial is evaluating triglyceride reduction and increasing functional HDL with K-877 (pemafibrate) in high-risk patients with diabetes with high triglyceride and low HDL-C levels who are already taking statins.
All PROMINENT participants receive aggressive, standard of care management of cardiovascular risk factors including treatment with high-intensity statins. In addition, patients receive either K-877 or placebo. The trial includes patients with high triglycerides and low HDL with diabetes with and without established cardiovascular disease, and will test whether K-877 reduces the occurrence of heart attacks, hospitalizations for unstable angina requiring unplanned revascularization, stroke, or death from cardiovascular causes.
Paul Ridker, MD, MPH, FACC, FAHA director of the Center for Cardiovascular Disease Prevention (CCVDP) at Brigham and Women's Hospital (BWH), a teaching affiliate of Harvard Medical School, and Aruna Pradhan, MD, a cardiologist at BWH, are co-Principal Investigators of PROMINENT.
"We are pleased to have achieved our goal to randomize 10,000 patients into PROMINENT," said Gary Gordon, MD, President, Kowa Research Institute, Inc. "Cardiovascular disease remains the number one cause of death worldwide. We will maintain focus on ensuring this important study is completed as planned to determine whether K-877 can be a new, valuable tool for physicians managing patients' cardiovascular disease."
About K-877 (pemafibrate)
About Kowa Company, Ltd. and Kowa Research Institute, Inc.
Kowa Research Institute, Inc., headquartered in Research Triangle Park, NC, is the division of Kowa responsible for the clinical development of Kowa's new drugs in the United States. Kowa Research Institute was established in 1997 in California and began operations at the current location in 2003. For more information about Kowa Research Institute, visit www.kowaus.com.
LIVALO and PARMODIA are registered trademarks of the Kowa group of companies.
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SOURCE Kowa Research Institute, Inc.