Phase 3
Completed N=45
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
Source: ClinicalTrials.gov NCT03962101 ↗Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Sep 2021
Primary outcomePrimary: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs — 77.8 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs |
77.8 | — |
| SECONDARY Change From Baseline in Body Weight |
-3.01 | — |
| SECONDARY Improvement Rate for Lower Limb Edema |
73.7 | — |
| SECONDARY Improvement Rate for Pulmonary Congestion |
81.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients receiving loop diuretic injection at a dose equivalent to furosemide 20 mg/day or higher
- CHF patients in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- Patients who are judged by the investigator or subinvestigator to have difficulty or be incapable of oral intake, including patients who are judged by the investigator or subinvestigator to require nothing by mouth(NPO) management
- Patients who are currently hospitalized or who are capable of being hospitalized from the time of informed consent until the end of the treatment period
- Patients who are capable of giving informed consent
Exclusion Criteria
- Patients who are on a ventricular assist device
- Patients who have difficulty with spontaneous respiration or who have been on tracheal intubation under sedative therapy
- Patients with severe disturbed consciousness (ie, coma or stupor)
Data sourced from ClinicalTrials.gov (NCT03962101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.