Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites
NCT ID: NCT01349335
Last Updated: 2012-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2009-04-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1. tolvaptan
15 mg, P.O., Qd, for 7 days,
Tolvaptan
tablet, 15 mg, Qd, for 7 days
2 tolvaptan
30 mg, P.O., Qd, for 7 days,
Tolvaptan
tablet, 30 mg, Qd, 7 days
3. Placebo
30mg,P.O.,Qd, for 7 days.
placebo
tablet, 30 mg, Qd, 7days.
Interventions
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Tolvaptan
tablet, 15 mg, Qd, for 7 days
Tolvaptan
tablet, 30 mg, Qd, 7 days
placebo
tablet, 30 mg, Qd, 7days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Hospitalized patients or those who can be hospitalized in this trial between observation period and posttherapeutic observation (Visits at clinic will be allowed after day 8);
3. During the observation period (-3 day to -1 day ), subjects whose body weight difference fall within ±1.0 kg range 2 days (day-2 and day -1) prior to initiation of trial drug treatment;
4. Ages: ≥18 and ≤75 years of age;
5. Genders: men or women;
6. Signed the Informed Consent Form.
Exclusion Criteria
* Hepatic encephalopathy (Coma scale Note 1) grade 2 or higher);
* Malignant ascites;
* Uncontrolled spontaneous bacterial peritonitis;
* Patients are likely to experience alimentary tract hemorrhage during the trial;
* Heart failure (NYHA cardiac function scale Note 2) stages 3 and 4);
* Anuria (daily urine volume below 100mL);
* Dysuria resulting from urethral stricture, calculus and tumors.
2. Patients with the following medical history:
* Alimentary tract hemorrhage within 10 days prior to screening;
* Cerebrovascular accident within 1 month prior to screening;
* Gout attack within 1 month prior to screening;
* Past allergy or hypersensitive reactions to benzodiazepines (e.g. benazepril hydrochloride)
3. Systolic pressure below 90mmHg at screening;
4. 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.
5. Patients cannot take drugs orally;
6. Pregnant or breast-feeding patients or women at child-bearing ages without taking acceptable contraceptive measures;
7. Patients received albumin or other blood preparations within 4 days prior to trial drug administration;
8. Patients participated in clinical trials of other drugs within 1 month prior to screening;
9. Patients participated in tolvaptan trials and took tolvaptan previously;
10. Patients are unsuitable to participate in this trial in investigators' opinion.
18 Years
75 Years
ALL
No
Sponsors
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Otsuka Beijing Research Institute
INDUSTRY
Responsible Party
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Principal Investigators
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Minde Zeng
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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156-08-804-01
Identifier Type: -
Identifier Source: org_study_id