NCT00234104

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Dose Response of OPC-41061 in Congestive Heart Failure Patients With Extracellular Volume Expansion

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure, Congestive
• Edema

Interventions

Type	Name	Description
DRUG	OPC-41061(Tolvaptan)

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2005-10-06
• Last updated: 2013-12-25
• Results posted: 2013-12-25

Locations

1 site across 1 country: Japan