Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
- Conditions
- Congestive heart failure
- Registration Number
- JPRN-jRCT2080224643
- Lead Sponsor
- Otsuka Pharmaceutical Co., LTD.
- Brief Summary
There was no unacceptable safety issues at the starting dose of 8 mg nor were there any marked differences in tolerability between subjects who maintained the dose at 8 mg or who increased dose to 16 mg. No clinically significant problems were observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 45
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method