Trial Profile
A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group, Non-inferiority Trial to Evaluate the Efficacy and Safety of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 14 Dec 2021
Price :
$35
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At a glance
- Drugs Tolvaptan (Primary) ; Tolvaptan (Primary)
- Indications Cardiac oedema; Heart failure
- Focus Registrational; Therapeutic Use
- Sponsors Otsuka Pharmaceutical
- 22 Mar 2021 According to an Otsuka Pharmaceutical media release, a NDA (New Drug Application) has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval of OPC-61815 for the treatment of cardiac edema.
- 21 Jan 2021 Status changed from active, no longer recruiting to completed.
- 29 Oct 2020 Planned End Date changed from 1 Jul 2020 to 1 Nov 2020.