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| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Tolvaptan | Experimental |
| |
| Drug: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria (for CHF):
Inclusion Criteria (for hepatic cirrhosis):
Inclusion Criteria (for SIADH and others):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fusheng Wang, PhD | Contact | fswang@public.bta.net.cn | ||
| Lin Zhu | Contact | 051885475957 | acetone_zhulin@yahoo.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, Beijing An Zhen Hospital Affiliated to Capital University of Medical Science | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others. |
|
| 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 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 |
| 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 |
| Endocrinology, Beijing Friendship Hospital | Recruiting | Beijing | China |
|
| Hepatology, No. 302 Hospital | Recruiting | Beijing | China |
|