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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00525265
Study type Interventional
Source Otsuka Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date September 2007
Completion date January 2009

See also
  Status Clinical Trial Phase
Completed NCT00544869 - A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure) Phase 3
Completed NCT01651156 - Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema Phase 3