drugset / Trial / NCT00544869

A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)

NCT00544869

Phase 3 Completed 52 enrolled Otsuka Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume expansion despite conventional diuretic therapy.

Timeline

Start
2007-10
Primary completion
2009-02
Completion
2009-02

Drugs

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