Trials / Completed
CompletedNCT03962101
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
A Multicenter, Open-label, Uncontrolled Clinical Trial to Confirm the Tolerability of OPC-61815 in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once daily for a maximum of 5 days to CHF patients with volume overload despite having received diuretics (injection) other than vasopressin antagonists and who have difficulty with or are incapable of oral intake.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-61815 injection | Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria. |
Timeline
- Start date
- 2019-06-17
- Primary completion
- 2020-06-30
- Completion
- 2020-06-30
- First posted
- 2019-05-23
- Last updated
- 2021-09-05
- Results posted
- 2021-09-05
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03962101. Inclusion in this directory is not an endorsement.