Cardiac edema (CHF)
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects receiving one of the following diuretic treatments (including subjects scheduled to start treatment during the run-in observation period 1) A loop diuretic at a daily dosage equivalent to 40 mg or more of furosemide 2) Concomitant administration of a loop diuretic and a thiazide diuretic (at any doses) 3) Concomitant administration of a loop diuretic and an anti-aldosterone drug (at any doses) (2) CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion. Patients with pulmonary congestion can be enrolled if pulmonary congestion is confirmed on chest x-ray taken within 14 days prior to the screening examination. (3) Male or female subjects age 20 or older and younger than 85 (at time of informed consent) (4) Subjects who are able to stay at the study site from the day before the start of the run-in observation period until completion of postdosing examination 2 (7 to 10 days after final study drug administration) (5) Subjects capable of giving informed consent to participate in the study of their own free will
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy, safety | — |
Outcome results
None listed