NCT03772041

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

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: Phase 3
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	OPC-61815	Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg
DRUG	Tolvaptan Tab 15 MG	Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo

Timeline

• Start date: 2019-01-16
• Primary completion: 2020-07-21
• Completion: 2020-07-29
• First posted: 2018-12-11
• Last updated: 2021-08-05
• Results posted: 2021-08-05

Locations

1 site across 1 country: Japan