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Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites

Sponsor
Otsuka Beijing Research Institute (Industry)
Overall Status
Completed
CT.gov ID
NCT01349335
Collaborator
(none)
180
Enrollment
1
Location
3
Arms
12
Duration (Months)
15
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Randomized, Double-blinded, Multicenter and Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Different Doses of Tolvaptan Tablet in Patients With Cirrhotic Ascites
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1. tolvaptan

15 mg, P.O., Qd, for 7 days,

Drug: Tolvaptan
tablet, 15 mg, Qd, for 7 days
Other Names:
  • SAMSCA

    		•
    Experimental: 2 tolvaptan

    30 mg, P.O., Qd, for 7 days,

    Drug: Tolvaptan
    tablet, 30 mg, Qd, 7 days
    Other Names:
  • SAMSCA

    		•
    Experimental: 3. Placebo

    30mg,P.O.,Qd, for 7 days.

    Drug: placebo
    tablet, 30 mg, Qd, 7days.
    Other Names:
  • blank tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Body weight changes after 7 days of treatment (quantity of changes) [from day1 to day7]

    Secondary Outcome Measures

    1. Body weight change after 4 days of treatment (quantity of changes) [from day1 to day4]

    2. Waist circumference after 4 and 7 days of treatment (quantity and rate of changes) [from day1 to day7]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. hepatic cirrhosis patients after 7days treatment of loop diuretics and aldosterone antagonist but still with ascites

    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:
    1. Patients with the following diseases, complications or symptoms:

    • 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.

    1. 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)

    1. Systolic pressure below 90mmHg at screening;

    2. 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.

    1. Patients cannot take drugs orally;

    2. Pregnant or breast-feeding patients or women at child-bearing ages without taking acceptable contraceptive measures;

    3. Patients received albumin or other blood preparations within 4 days prior to trial drug administration;

    4. Patients participated in clinical trials of other drugs within 1 month prior to screening;

    5. Patients participated in tolvaptan trials and took tolvaptan previously;

    6. Patients are unsuitable to participate in this trial in investigators' opinion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renji hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 200001

    Sponsors and Collaborators

    • Otsuka Beijing Research Institute

    Investigators

    • Principal Investigator: Minde Zeng, RenJi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Otsuka Beijing Research Institute
    ClinicalTrials.gov Identifier:
    NCT01349335
    Other Study ID Numbers:
    • 156-08-804-01
    First Posted:
    May 6, 2011
    Last Update Posted:
    Oct 12, 2012
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Fibrosis
    Ascites
    Tolvaptan

    Study Results

    No Results Posted as of Oct 12, 2012