drugset / Trial / NCT00525265

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

NCT00525265

Phase 3 Completed 20 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-09
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 7.5 mg Oral
Subject Tolvaptan Small molecule 15 mg Oral