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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional




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

Brief 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.