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EFFECTS OF VESNARINONE IN PATIENTS WITH HEART FAILURE

Principal Investigator:  Raymond P. Bain, Ph.D.

 
For the Effects of Vesnarinone in Patients with Heart Failure trail The Biostatistics Center was the Biostatistical analysis center of this multi-center clinical trial of the oral inotropic agent vesnarinone. The vesnarinone trial was a double-masked, placebo-controlled, multiple-dose, randomized clinical trial designed to evaluate the safety and efficacy of the oral inotropic agent vesnarinone on cardiovascular morbidity and mortality in participants with symptomatic chronic heart failure and left ventricular dysfunction. Over a two-year period in 22 clinical sites, the vesnarinone trial randomized a total of 564 participants. Participants were randomized to placebo or either a low or high dose of vesnarinone. Randomized participants were followed for six months. The vesnarinone trial concluded that six months of therapy with 60 mg of vesnarinone per day resulted in lower morbidity and mortality and improved the quality of life of patients with congestive heart failure (NEJM 1993;329:149-155).

Funded by Otsuka America Pharmaceutical, Inc., 1989-1992.)