drugset / Trial / NCT00234104

A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)

NCT00234104

Phase 2 Completed 122 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

This drug is being developed to treat cardiac edema. The primary purpose of this study is to investigate the dose response for body weight in seven-day repeated oral administration of OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion secondary to CHF despite taking furosemide at 40 mg/d or more. This study is being conducted in Japan.

Timeline

Start
2004-08
Primary completion
2006-01
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 15 mg Oral
Subject Tolvaptan Small molecule 30 mg Oral
Subject Tolvaptan Small molecule 45 mg Oral