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ECLIPSE Data on Effects of Otsuka's Investigational Novel Treatment, Tolvaptan, on Advanced Heart Failure Patients' Hemodynamics and Urine Output Featured in Heart Failure Society of America's Late Breaking Trials
Date:9/19/2007

out ECLIPSE

ECLIPSE is an international, multicenter, randomized, placebo-controlled single-dose trial conducted at 48 trials sites in United States, Romania and Bulgaria between 2005 and 2006. ECLIPSE investigators enrolled patients with heart failure (New York Heart Association Class III or IV) for at least three months duration due to left ventricular systolic dysfunction and who had a left ventricular ejection fraction (LVEF) of 40 percent or less.

Investigators assessed patients' inclusion criteria for up to two weeks prior to randomization. Suitable candidates underwent insertion of a balloon- floatation pulmonary artery catheter to assess final eligibility criteria. Final doses of cardiac concomitant medications were administered at least two hours prior to catheter insertion. Following catheter insertion, patients entered into a two- to 20-hour stabilization period. Researchers completed hemodynamic assessments periodically during this period to determine final subject eligibility. Potential participants then entered a two-hour baseline period. If a participant met all criteria during the baseline period, he or she was randomly assigned to one of four groups and received a single once- daily oral tablet of placebo or of 15, 30 or 60 milligrams (mg) tolvaptan. Investigators followed participants for up to 24 hours for assessments.

"The ECLIPSE data add` to our existing knowledge about tolvaptan and its prospective uses," said Taro Iwamoto, CEO, COO and President of Otsuka Pharmaceutical Development & Commercialization, Inc. "Tolvaptan, as one of our most advanced candidate therapies, represents the successful application of Otsuka's expertise in the research and development of new medicines."

About Heart Failure

More than 14 million people in Europe(1) and five million U.S. residents(2) have heart failure (HF), a serious chronic condition in which the heart cannot effectively pump blood. The direct and indirect U.S. health care e
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SOURCE Otsuka America Pharmaceutical, Inc.
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