drugset / Trial / NCT00525265
A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolvaptan | Small molecule | 7.5 mg | Oral |
| Subject | Tolvaptan | Small molecule | 15 mg | Oral |