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To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis with ascites and exploring the dosage-effect relations of the drug.
Tolvaptan is able to exert hydragogue diuretic effects (water diuresis) via inhibition of water reabsorption by renal collecting ducts without corresponding increase in electrolyte excretion. It has been confirmed that tolvaptan is able to increase urine volume without any adverse effects on renal functions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. tolvaptan | Experimental | 15 mg, P.O., Qd, for 7 days, |
|
| 2 tolvaptan | Experimental | 30 mg, P.O., Qd, for 7 days, |
|
| 3. Placebo | Experimental | 30mg,P.O.,Qd, for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | tablet, 15 mg, Qd, for 7 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight changes after 7 days of treatment (quantity of changes) | from day1 to day7 |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight change after 4 days of treatment (quantity of changes) | from day1 to day4 | |
| Waist circumference after 4 and 7 days of treatment (quantity and rate of changes) | from day1 to day7 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with the following diseases, complications or symptoms:
Patients with the following medical history:
Systolic pressure below 90mmHg at screening;
Patients with the following abnormalities in laboratory examinations at screening:
Serum creatinine exceeds 2.5X upper limits of normal, serum Na+>145mmol/L (or exceeds upper limits of normal), serum K+>5.5mmol/L, uric acid>8.0mg/dL (476μmol/L), Child-pugh scale greater than 12.
Patients cannot take drugs orally;
Pregnant or breast-feeding patients or women at child-bearing ages without taking acceptable contraceptive measures;
Patients received albumin or other blood preparations within 4 days prior to trial drug administration;
Patients participated in clinical trials of other drugs within 1 month prior to screening;
Patients participated in tolvaptan trials and took tolvaptan previously;
Patients are unsuitable to participate in this trial in investigators' opinion.
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| Name | Affiliation | Role |
|---|---|---|
| Minde Zeng | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200001 | 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. |
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| ID | Term |
|---|---|
| D001201 | Ascites |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System 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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| Tolvaptan | Drug | tablet, 30 mg, Qd, 7 days |
|
|
| placebo | Drug | tablet, 30 mg, Qd, 7days. |
|
|
| D005355 | Fibrosis |