drugset / Trial / NCT00462670

A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

NCT00462670

Phase 3 Completed 110 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional diuretic.

Timeline

Start
2007-04
Primary completion
2008-10
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 15 mg Oral