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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224643

Enrollment

Registered

2019-04-16

Start date

2019-06-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive heart failure

Interventions

investigational material(s) Generic name etc : OPC-61815 INN of investigational material : tolvaptan Therapeutic category code : 213 Diuretics Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients receiving loop diuretic injection at a dose equivalent to furosemide 20 mg/day or higher 2. CHF patients in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present 3. 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 4. 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 5. Patients who are capable of giving informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who are on a ventricular assist device 2. Patients who have difficulty with spontaneous respiration or who have been on tracheal intubation under sedative therapy 3. Patients with severe disturbed consciousness (ie, coma or stupor)

Design outcomes

Primary

Measure	Time frame
safety Adverse events (AEs)	—

Secondary

Measure	Time frame
efficacy - Body Weight - Improvement Rate for Lower Limb Edema - Improvement Rate for Pulmonary Congestion	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026