A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

Inclusion criteria

• Subjects with cardiac edema receiving diuretic treatments 7 days prior to the start of treatment.
• Subjects able to receive a daily regular dosage of furosemide at 40-mg to 80-mg from the observation period until the end-of-treatment examination.
• CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
• Male or female subjects between the age of 20 and 85, inclusive.
• Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-dosing examination 2.
• Subjects capable of giving informed consent to participate in the study of their own free will.

Exclusion criteria

• Subjects with heart failure with markedly fluctuating symptoms.
• Subjects with an assisted circulation device.
• Subjects with any of the following complications or symptoms:(1)Suspected decrease in circulatory blood flow,(2)Hypertrophic cardiomyopathy (other than dilated phase),(3)Cardiac valve disease with significant heart valve stenosis,(4)Hepatic coma.
• Subjects who develop acute myocardial infarction within 30 days prior to the screening examination.
• Subjects with well-defined diagnosis of active myocarditis or amyloid cardiomyopathy.
• Subjects with any of the following complications or symptoms:(1)Diabetes mellitus with poorly controlled blood glucose,(2)Anuria,(3)Urination impaired due to urinary tract stricture,urinary calculus,tumor in urinary tract,or other cause.
• Subjects with a history of any of the following diseases:(1)Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination in patients without an implanted defibrillator,(2)Cerebrovascular disorder within 6 months prior to the screening examination (other than asymptomatic cerebral infarction),(3)Hypersensitivity or idiosyncratic reaction to benzazepine derivatives.
• Subjects who are morbidly obese (body mass index exceeding 35).
• Subjects with systolic blood pressure in the decubitus position below 90 mmHg.
• Subjects with any of the following abnormal laboratory values:(1)Total bilirubin > 3.0 mg/dL,(2) serum creatinine > 3.0 mg/dL,(3)serum sodium > 147 mEq/L,(4)serum potassium > 5.5 mEq/L.
• Subjects who are unable to take oral medication.
• Female subjects who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant.
• Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination.
• Subjects who previously participated in this or any other study of OPC-41061 and received OPC-41061.
• Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study.