Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites

Exclusion Criteria

• •1. Patients with any of the following diseases, complications or symptoms:
• •* Hepatic encephalopathy (hepatic coma of grade II or higher1）);
• •* Malignant ascites (patients have tumor cells detected in ascites if malignant ascites be highly suspected);
• •* Uncontrolled spontaneous bacterial peritonitis;
• •* Patients who are likely to experience alimentary tract hemorrhage during the study;
• •* Heart failure (NYHA2） grade III or IV);
• •* Anuresis (daily urine volume is less than 100mL);
• •* Dysuria due to urinary tract stricture, urinary calculus, tumor in the urinary tract or other cause.
• •2. Patients with history of :
• •* Alimentary tract hemorrhage within 10 days prior to screening;
• •* Cerebral accident suffered within 30 days prior to screening;
• •* Past history of hypersensitivity or idiosyncratic reaction to benzazepine derivatives (Benazepril).
• •3. Patients with systolic pressure below 90mmHg at screening;
• •4. Patients with any of the following abnormal laboratory parameters at screening:
• •* Serum creatinine \>1.5x upper limit of normal range;
• •* Serum Na+\>145mmol/L (or higher than upper limit of normal range);
• •* Serum K+\>5.5mmol/L;
• •5. Patients with Child-pugh score3）\>12;
• •6. Patients who are unable to take medicine orally;
• •7. Female patients who are pregnant, lactating, or who are at child-bearing age without using acceptable contraceptive means;
• •8. Patients who received blood products including albumin within 4 days prior to the initiation of treatment
• •9. Patients who participated in any clinical trial other than tolvaptan within one month prior to screening;
• •10. Patients who participated in Tolvaptan trials and took Tolvaptan previously;
• •11. Patients otherwise judged by the investigator, to be inappropriate for inclusion in the study.