NCT00544869

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

Phase 3 Open-label, Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure) - an Investigation of the Safety of Treatment Beyond 7 Days and the Effect of Dose Escalation to 30 mg

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Edema

Interventions

Type	Name	Description
DRUG	OPC-41061 （Tolvaptan)	15-30mg/day,daily for 14days

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-10-16
• Last updated: 2014-01-30
• Results posted: 2014-01-30

Locations

6 sites across 1 country: Japan