Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
- Conditions
- Congestive heart failure
- Registration Number
- JPRN-jRCT2080223620
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
OPC-41061 exposure (Cmax and AUC24h) on Day 1 following single intravenous administration of OPC-61815 at 16 mg was the most similar to that following single administration of tolvaptan 15-mg tablet. There was no marked difference in tolerability between OPC-61815 at 16 mg and tolvaptan 15-mg tablet, and no clinically significant problems were observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 61
1. Subjects who are currently on treatment with any of the following diuretics
- Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
- Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
- Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
2. Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
3. Subjects who are currently hospitalized or who are able to be hospitalized during the trial
1. Subjects with acute heart failure
2. Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
3. Subjects who are unable to sense thirst or who have difficulty with fluid intake
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>Tolvaptan exposure
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacodynamics<br>Adverse Event