Clinical trial
Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg…
NCT03772041 · Otsuka Pharmaceutical Co., Ltd., Industry · Completed
Key facts
| NCT number | NCT03772041 |
|---|---|
| Title | Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure |
| Official title | 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 |
| Lead sponsor | Otsuka Pharmaceutical Co., Ltd., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Congestive Heart Failure |
| Intervention type | Drug |
| Interventions | OPC-61815, Tolvaptan Tab 15 MG |
| Enrollment | 294 |
| Start date | Jan 16, 2019 |
| Primary completion | Jul 21, 2020 |
| Completion | Jul 29, 2020 |
| First posted | Dec 11, 2018 |
| Last update posted | Aug 5, 2021 |
| Countries | Japan |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: