NCT00462670

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Edema, Cardiac

Interventions

Type	Name	Description
DRUG	OPC-41061(Tolvaptan)	0, 15mg of OPC-41061 per day for 7days p.o. administration

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-04-19
• Last updated: 2014-02-04
• Results posted: 2014-02-04

Locations

8 sites across 1 country: Japan