drugset / Trial / NCT00544869
A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-10
- Primary completion
- 2009-02
- Completion
- 2009-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolvaptan | Small molecule | 15 mg | Oral |
| Subject | Tolvaptan | Small molecule | 30 mg | Oral |