This drug has been developed to treat Hyponatremia. The primary purpose of this study is to verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15, 30, and 60 mg or placebo in patients with Non-hypovolemic Non-acute Hyponatremia secondary to Congestive Heart Failure (CHF), hepatic cirrhosis or Syndrome of Inappropriate Antidiuretic Hormone (SIADH), despite receiving standard therapy. This study is being conducted in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Tablet;15mg/tab; 30mg/tab; 15/30/60mg/day for 7 days Plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.
placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.
Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science
Beijing, China
RECRUITINGEndocrinology, Beijing Friendship Hospital
Beijing, China
RECRUITINGHepatology, No. 302 Hospital
Beijing, China
RECRUITINGThe change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period
Time frame: 4 and 7 days
Percentage of patients with normalized serum sodium at Day 4
Time frame: 4 day
Percentage of patients with normalized serum sodium at Day 7
Time frame: 7 day
Time to first normalization in serum sodium
Time frame: up to 7 days
Change from baseline in serum sodium at Day 4
Time frame: 4 day
Change from baseline in serum sodium at Day 7
Time frame: 7 day
Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study
Time frame: up to 7 days
24-hour urine output
Time frame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Change from baseline in body weight (hypervolemic patients only)
Time frame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Fluid balance (hypervolemic patients only)
Time frame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
The percentage of patients who are designated as treatment failure due to the need for saline infusion, with or without fluid restriction
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Time frame: up to 7 days
For CHF patients, improvement of symptoms and relevant physical examination measures
Time frame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7
For hepatic edema patients, improvement of symptoms and relevant physical examination measures or ultrasound test findings
Time frame: day 1, day 2, day 3, day 4, day 5, day 6 and day 7