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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy + placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of patients with non-hypovolemic non-acute hyponatremia arising from a variety of etiologies. 240 (120 in each group) patients are to be enrolled randomly into Tolvaptan group or placebo group. Subjects in Tolvaptan group will receive standard therapy + Tolvaptan (15-60mg/day), while those in control group receiving standard therapy + placebo. The starting dose of tolvaptan is 15mg and it could be titrated up to 30mg and then,if necessary, to the maximum of 60mg according to a certain titration scheme based on patients' response of serum sodium level. The study includes a 2-day screening period from day -2 to day -1, 7-day inpatient study treatment (day 1 to day 7 ). After study treatment, subjects will be Followed-up on safety events on day 14 - 16. The Primary Efficacy Variable is the change of serum sodium from baseline. For patients with Congestive Heart Failure (CHF) or hepatic cirrhosis, change of body weight, fluid balance and symptoms improvement of CHF and hepatic edema will be assessed as secondary efficacy variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | Tablet;15mg/tab;15/30/60mg/day for 7days Plus conventional therapy according to each patient's underlying disease, such as congestive heart failure, 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 |
|---|---|---|
| For CHF and hepatic edema patients, improvement of symptoms and relevant physical examination measures or ultrasound test findings . Other secondary efficacy variables on blood serum sodium, fluid balance or body weight change. | 4 or 7 days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenling Zhu | Peking Union Medical College Hospital | Principal Investigator |
| Feng Gu | Peking Union Medical College Hospital | Principal Investigator |
| Jidong Jia | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, the Third Xiangya Hospital, Central South University | Changsha | Hunan | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30180806 | Derived | Wang S, Zhang X, Han T, Xie W, Li Y, Ma H, Liebe R, Weng H, Ding HG. Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia. BMC Gastroenterol. 2018 Sep 4;18(1):137. doi: 10.1186/s12876-018-0857-0. | |
| 24906029 | Derived | Chen S, Zhao JJ, Tong NW, Guo XH, Qiu MC, Yang GY, Liu ZM, Ma JH, Zhang ZW, Gu F. Randomized, double blinded, placebo-controlled trial to evaluate the efficacy and safety of tolvaptan in Chinese patients with hyponatremia caused by SIADH. J Clin Pharmacol. 2014 Dec;54(12):1362-7. doi: 10.1002/jcph.342. |
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| Placebo | Drug | placebo plus conventional therapy according to each patient's underlying disease, such as congestive heart failure, hepatic cirrhosis and SIADH or others. |
|
| Department of Cardiology, Xiangya Hospital, Central South University |
| Changsha |
| Hunan |
| China |
| Cardiology, Jilin University Second Hospital | Changchun | Jilin | China |
| Endocrinology, West China Hospital Sichuan University | Chengdu | Sichuan | China |
| Cardiology / Endocrinology, Peking Union Medical College Hospital | Beijing | China |
| Cardiology / Hepatology, Beijing Friendship Hospital | Beijing | China |
| Cardiology/Endocrinology/Infection, Beijing University First Hospital | Beijing | China |
| Endocrinology, No. 301 hospital | Beijing | China |
| Hepatology, Beijing Renmin Hospital | Beijing | China |
| Hepatology/Endocrinology, Chongqing Medical University Second Hospital | Chongqing | China |
| Hepatology / Endocrinology, Shanghai Changzheng Hospital | Shanghai | China |
| Cardiology, Tianjin Medical University Second Hospital | Tianjin | China |
| Endocrinology, Tianjin General Hospital | Tianjin | China |
| 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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