Phase 3 open-label study of OPC-41061 in subjects with cardiac-induced edema (congestive heart failure) - an investigation of the safety of treatment beyond 7 days and the effect of dose escalation to 30 mg
- Conditions
- Cardiac edema (CHF)
- Registration Number
- JPRN-jRCT2080220454
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
1) Subjects receiving one of the following diuretic treatments (including Subjects with cardiac edema receiving diuretic treatments 7 days prior to the start of treatment.
2) Subjects receiving one of the following diuretic treatments since 3 days prior to the commencement of study drug administration without changing the dose or dosing regimen (including subjects scheduled to start treatment during the run-in observation period).
- A loop diuretic at a daily dosage equivalent to 40 mg or more of furosemide
- Concomitant administration of a loop diuretic and a thiazide diuretic (at any doses)
- Concomitant administration of a loop diuretic and an anti-aldosterone drug (at any doses)
3) CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
4) Male or female subjects between the ages of 20 and 85, inclusive (at time of informed consent)
5) Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-treatment observation 2 (7 to 10 days after final study drug administration)
6) Subjects capable of giving informed consent to participate in the study of their own free will
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy, safety
- Secondary Outcome Measures
Name Time Method