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

Cardiac Edema Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Edema
• Edema
• Edema, Cardiac
• Heart Failure

• NCT number: NCT00544869
• Study type: Interventional
• Source: Otsuka Pharmaceutical Co., Ltd.
• Status: Completed
• Phase: Phase 3
• Start date: October 2007
• Completion date: February 2009