Overview

Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

Status:
Completed

Trial end date:
2020-07-29

Target enrollment:

Participant gender:

Summary

To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF patients with volume overload despite having received diuretics other than vasopressin antagonists

Phase:

Phase 3

Details

Lead Sponsor:

Otsuka Pharmaceutical Co., Ltd.

Treatments:

Tolvaptan