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

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: NCT01349335
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : October 12, 2012
Information provided by (Responsible Party):
Otsuka Beijing Research Institute

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
Ascites Hepatic Cirrhosis Drug: Tolvaptan Drug: placebo 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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan

Arm Intervention/treatment
Experimental: 1. tolvaptan
15 mg, P.O., Qd, for 7 days,
Drug: Tolvaptan
tablet, 15 mg, Qd, for 7 days
Other Name: SAMSCA

Experimental: 2 tolvaptan
30 mg, P.O., Qd, for 7 days,
Drug: Tolvaptan
tablet, 30 mg, Qd, 7 days
Other Name: SAMSCA

Experimental: 3. Placebo
30mg,P.O.,Qd, for 7 days.
Drug: placebo
tablet, 30 mg, Qd, 7days.
Other Name: blank tablet

Primary Outcome Measures :
  1. Body weight changes after 7 days of treatment (quantity of changes) [ Time Frame: from day1 to day7 ]

Secondary Outcome Measures :
  1. Body weight change after 4 days of treatment (quantity of changes) [ Time Frame: from day1 to day4 ]
  2. Waist circumference after 4 and 7 days of treatment (quantity and rate of changes) [ Time Frame: from day1 to day7 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01349335

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China, Shanghai
Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200001
Sponsors and Collaborators
Otsuka Beijing Research Institute
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Principal Investigator: Minde Zeng RenJi Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Otsuka Beijing Research Institute Identifier: NCT01349335    
Other Study ID Numbers: 156-08-804-01
First Posted: May 6, 2011    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: May 2011
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs