Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01359462
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : May 24, 2011
Information provided by:
Otsuka Beijing Research Institute

March 5, 2010
May 24, 2011
May 24, 2011
April 2009
November 2009   (Final data collection date for primary outcome measure)
Serum concentration of tolvaptan and its metabolites DM-4103 and DM-4107 [ Time Frame: blood sample will be collected at predose, 2,4,6,8,12,24 hour of first drug administration and predose of sixth drug administration and predose,2,4,6,8,12,24 hour of seventh drug administration ]
Same as current
No Changes Posted
  • pharmacological parameter:Serum concentration of sodium and potassium [ Time Frame: Blood sample will be collected at predose on day1;12,24hour of first dosing;before breakfast on day3 to day6;predose and 12,24hour of seventh dosing ]
  • pharmacological parameter:24-hr urine [ Time Frame: From day-1 to day 8 ]
Same as current
Not Provided
Not Provided
Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis
A Clinical Study of Multiple-dose Pharmacokinetics of Tolvaptan Tablets Administered Orally (15mg Daily) for Consecutively 7 Days in Chinese Patients With Hepatocirrhosis
For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.

This study is to evaluate the multiple-dose pharmacokinetics, pharmacological actions and safety of Tolvaptan tablets administered orally (15 mg daily) for consecutively 7 days in Chinese adult patients with confirmed Child-Pugh Class B(score 7-9) hepatocirrhosis (accompanied by ascites).

Trial Design:

  1. Open, single-center, multi-dose pharmacokinetics study
  2. Study population:

    Chinese adult patients with confirmed Child-Pugh Class B (score 7-9) hepatocirrhosis (accompanied by ascites)

  3. Dosage and mode of administration of investigational product:

    Oral administration of 1 tablet (15mg) once daily, for consecutive 7 days starting from day 1 of treatment.

  4. Study duration:

Screening: 14 days in maximum; Treatment(s): 7 days; Observation: 1 day

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hepatic Cirrhosis
  • Ascites
Drug: tolvaptan

Drug: tolvaptan

tablet, 15mg, Qd, for 7 days.

Other Name: SAMSCA
Experimental: Tolvaptan 15mg tablet
Intervention: Drug: tolvaptan
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2010
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Hepatic Cirrhosis with ascites or lower extremities edema
  2. Hospitalized patients
  3. 18 years old~75 years old
  4. Inform Consent Form Signed

Exclusion Criteria:

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

    • Hepatic encephalopathy (coma degree classification note 1 Grade 2 or above);
    • Malignant ascites;
    • Spontaneous bacterial peritonitis;
    • Likely to have gastrointestinal bleeding during the study period;
    • Heart failure (NYHA Note 2 Class Ⅲ andⅣ);
    • Anuria (daily urine output below 100mL);
    • Dysuria induced by urinary tract stenosis, calculus, or tumor.
  2. Patients with any of the following history:

    • With gastrointestinal bleeding within 10 days prior to screening;
    • With cerebrovascular accident within 1 month prior to screening;
    • With gout attack within 1 month prior to screening;
    • With allergy or atopy to benzodiazepine drugs (benazepril hydrochloride, etc.).
  3. Patients whose systolic blood pressure is below 90mmHg during screening;
  4. Patients with abnormal values in the following lab examination indicators:

    Serum creatinine higher than 2.5 times the upper limit of normal range, serum Na+>145mmol/L(or higher than the upper limit of normal range), serum K+> 5.5 mmol/L, uric acid>476µmol/L, child-Pugh score>10

  5. Patients ineligible for oral medication
  6. Patients in pregnancy or lactation; female of childbearing potential not taking contraceptive measures;
  7. Patients having taken blood products including albumin products within 4 days prior to application of investigational product;
  8. Patients having participated in clinical trials of other drugs within 1 month prior to screening;
  9. Patients used to participate in clinical trials of Tolvaptan and take the said drug;
  10. Patients determined by the investigator as illegible for the study.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Ms. Feng Yan, Otsuka Beijing Research Institute
Otsuka Beijing Research Institute
Not Provided
Principal Investigator: Minde Zeng RenJi Hospital
Otsuka Beijing Research Institute
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP