Status:
COMPLETED
Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
20-85 years
Phase:
NA
Brief Summary
The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 i...
Eligibility Criteria
Inclusion
- 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
- Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- Subjects who are currently hospitalized or who are able to be hospitalized during the trial
Exclusion
- Subjects with acute heart failure
- Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
- Subjects who are unable to sense thirst or who have difficulty with fluid intake
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2018
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03254108
Start Date
November 6 2017
End Date
April 24 2018
Last Update
July 28 2021
Active Locations (1)
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1
Kanto, Japan