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

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

Timeline

Start

2019-01-16

Primary completion

2020-07-21

Completion

2020-07-29

Outcome

Met primary endpoint

release “phase 3 trial outcomes showed non-inferiority of OPC-61815 versus tolvaptan 15mg tablet in the primary endpoint” otsuka.co.jp ↗

Drugs

Indications