Status:
COMPLETED
Efficacy and Safety Trial of OPC-61815 Injection Compared With 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:
PHASE3
Brief Summary
To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16...
Eligibility Criteria
Inclusion
- Patients 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
- Patients with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- Patients who are currently hospitalized or who are able to be hospitalized during the trial
Exclusion
- Patients with acute heart failure
- Patients who are on a ventricular assist device
- Patients who are unable to sense thirst or who have difficulty with fluid intake
Key Trial Info
Start Date :
January 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2020
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT03772041
Start Date
January 16 2019
End Date
July 29 2020
Last Update
August 5 2021
Active Locations (1)
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1
Saiseikai Kumamoto Hospital
Kumamoto, Japan