BioCentury
ARTICLE | Clinical News

Gencaro bucindolol: Phase IIb/III started

April 21, 2014 7:00 AM UTC

Arca began the double-blind, placebo-controlled, U.S. Phase IIb/III GENETIC-AF trial to compare 6.25, 12.5, 25, 50 and 100 mg oral Gencaro twice daily vs. 25, 50, 100 and 200 mg oral Toprol-XL metoprolol succinate twice daily in about 620 patients with a genetic variant of ADRB1 who have heart failure and reduced left ventricular ejection fraction (LVEF). Laboratory Corp. of America Holdings (NYSE:LH, Burlington, N.C.) is genotyping the patients. The company and Arca are collaborating to develop a companion diagnostic.

The Phase IIb portion will enroll about 200 patients, and the Phase III portion will enroll an additional 420 patients. Arca will also conduct a substudy with Medtronic to continuously monitor cardiac rhythms of all patients in the Phase IIb portion. The substudy will measure AF burden, defined as a patient's actual time in AF regardless of symptoms. ...