A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)

Exclusion Criteria

• •1. Patients with unstable heart failure (acute heart failure, acute exacerbation of chronic heart failure, etc)
• •2. Patients with an implanted ventricular assist device
• •3. 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
• •4. Patients with any of the following diseases, complications, or symptoms
• •* Suspected hypovolemia
• •* Onset of acute myocardial infarction within 30 days prior to the screening examination
• •* Hypertrophic cardiomyopathy (excluding diastolic phase)
• •* Definitively diagnosed active myocarditis or amyloid cardiomyopathy
• •* Valvular heart disease with significant stenosis
• •* Untreated thyroid disease
• •* Progressive neurological disease (Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc) or severe episodic neurological disease (epilepsy, Guillain-Barre syndrome, etc)
• •* Diabetes with poor glycemic control
• •* Anuria
• •* Hepatic coma
• •* Hyponatremia of moderate or greater severity (serum Na \< 120 mEq/L)
• •5. Patients with a history of the following conditions
• •* Occurrence of sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination (except for patients using an implantable cardioverter-defibrillator)
• •* Evident cerebral infarction
• •* Multiple stroke
• •* Occurrence of a cerebrovascular accident within 30 days prior to the screening examination
• •* Hypersensitivity or idiosyncratic reaction to benzazepine derivatives, such as benazapril
• •6. Patients with a history of drug abuse or alcoholism in the past year
• •7. Patients in a state of morbid obesity with a body mass index (weight\[kg\] ÷ height \[m\]2) over 35
• •8. Patients with a supine systolic arterial blood pressure of less than 90 mmHg
• •9. Patients with any of the following abnormal laboratory values: Hemoglobin \<9 g/dL, total bilirubin \>3.0 mg/dL, serum creatine \>3.0 mg/dL, serum Na \>147 mEq/L, or serum K \>5.5 mEq/L
• •10. Patients not capable of taking oral medication
• •11. Patients who are nursing, pregnant, capable of pregnancy, or intending to become pregnant during or shortly after the study period
• •12. Patients who have taken a study drug other than OPC-41061 within 30 days prior to screening
• •13. Patients who have previously taken OPC-41061 in this study or another study of OPC-41061
• •14. Patients otherwise judged by the principal investigator or attending investigator to be inappropriate for inclusion in the study (eg, patients with hepatic cirrhosis, renal disease, etc.)