Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
- Registration Number
- NCT01507727
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug: Placebo Placebo - Drug: Tolvaptan Tolvaptan -
- Primary Outcome Measures
Name Time Method The 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 4 and 7 days
- Secondary Outcome Measures
Name Time Method For CHF patients, improvement of symptoms and relevant physical examination measures day 1, day 2, day 3, day 4, day 5, day 6 and day 7 Percentage of patients with normalized serum sodium at Day 4 4 day Percentage of patients with normalized serum sodium at Day 7 7 day Time to first normalization in serum sodium up to 7 days Change from baseline in serum sodium at Day 4 4 day Change from baseline in serum sodium at Day 7 7 day Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study up to 7 days 24-hour urine output day 1, day 2, day 3, day 4, day 5, day 6 and day 7 Change from baseline in body weight (hypervolemic patients only) day 1, day 2, day 3, day 4, day 5, day 6 and day 7 Fluid balance (hypervolemic patients only) 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 up to 7 days For hepatic edema patients, improvement of symptoms and relevant physical examination measures or ultrasound test findings day 1, day 2, day 3, day 4, day 5, day 6 and day 7
Trial Locations
- Locations (3)
Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science
🇨🇳Beijing, China
Hepatology, No. 302 Hospital
🇨🇳Beijing, China
Endocrinology, Beijing Friendship Hospital
🇨🇳Beijing, China