A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)
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This drug is being developed to treat cardiac edema. The primary purpose of this study is to investigate the dose response for body weight in seven-day repeated oral administration of OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion secondary to CHF despite taking furosemide at 40 mg/d or more. This study is being conducted in Japan.
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Ages Eligible for Study:
20 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with CHF who exhibit edema, jugular venous distention, hepatomegaly, pulmonary congestion, or 3rd sound due to extracellular volume expansion
Hospitalized patients or patients who can be hospitalized for the study from the commencement of the observation period to the end-of-study examination
Men and women between the ages of 20 and 80 (non-inclusive) at the time of giving consent
Patients who have taken furosemide at 40 mg/d or more (oral dosing) without alteration of dosage for the 3 days of the observation period
Patients whose body weight has been stable (±1.0 kg) for 2 days prior to commencement of study drug administration
Patients with unstable heart failure (acute heart failure, acute exacerbation of chronic heart failure, etc)
Patients with an implanted ventricular assist device
Patients who have undergone or are scheduled to undergo any of the following procedures
Heart surgery involving thoracotomy within 60 days prior to the screening examination
Pacemaker implant surgery involving bilateral pacing within 60 days prior to the screening examination
Angioplasty, electrophysiologic device implantation, ventricular assist device implantation, heart transplant, or other cardiac surgery scheduled within 30 days after the screening examination
Patients with any of the following diseases, complications, or symptoms
Onset of acute myocardial infarction within 30 days prior to the screening examination