NCT00525265

A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

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

Summary

To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.

Conditions

• Cardiac Edema

Interventions

Type	Name	Description
DRUG	OPC-41061(Tolvaptan)	Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days.
DRUG	Placebo	Subjects will be orally administered placebo once daily after breakfast for seven days.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-09-05
• Last updated: 2013-12-25
• Results posted: 2013-12-25

Locations

2 sites across 1 country: Japan