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Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia

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ClinicalTrials.gov Identifier: NCT01890694
Recruitment Status : Terminated
First Posted : July 2, 2013
Results First Posted : April 11, 2016
Last Update Posted : December 11, 2017
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
New York University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Hyponatremia
Interventions: Drug: Tolvaptan
Drug: Placebo
Behavioral: Hepatic Encephalopathy Assessment
Behavioral: Quality of Life Assessment
Biological: Vital signs
Biological: Blood laboratory tests
Procedure: Ascites Evaluation
Procedure: Edema

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Subjects will receive placebo once daily.
Tolvaptan Subjects will receive 15 mg Tolvaptan once daily.

Participant Flow:   Overall Study
    Placebo   Tolvaptan
STARTED   1   1 
COMPLETED   0   0 
NOT COMPLETED   1   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Subjects will receive placebo once daily.
Tolvaptan Subjects will receive 15 mg Tolvaptan once daily.
Total Total of all reporting groups

Baseline Measures
   Placebo   Tolvaptan   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   1   2 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1 100.0%      1 100.0%      2 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      1 100.0%      1 100.0%      2 100.0% 


  Outcome Measures

1.  Primary:   Length of Hospital Stay   [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]

2.  Secondary:   Severity of Hepatic Encephalopathy   [ Time Frame: Day 2 ]

3.  Secondary:   Severity of Hepatic Encephalopathy   [ Time Frame: Day 4 ]

4.  Secondary:   Severity of Hepatic Encephalopathy   [ Time Frame: Day 6 ]

5.  Secondary:   Severity of Hepatic Encephalopathy   [ Time Frame: Day 8 ]

6.  Secondary:   Severity of Hepatic Encephalopathy   [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]

7.  Secondary:   Severity of Hepatic Encephalopathy   [ Time Frame: Week 1-4 Post-discharge ]

8.  Secondary:   Severity of Hepatic Encephalopathy   [ Time Frame: Months 2-6 post-discharge ]

9.  Secondary:   Ascites   [ Time Frame: Day 1 to Post-discharge (6 months) ]

10.  Secondary:   Renal Function [BUN and Creatinine Laboratory Results]   [ Time Frame: Day 1 to Post-discharge (6 months) ]

11.  Secondary:   Hospital Readmission Rate   [ Time Frame: Post-Discharge (6 months) ]

12.  Secondary:   Survival   [ Time Frame: Post-discharge (6 months) ]

13.  Secondary:   Neutrophil Function [Results From the Assay of Neutrophils]   [ Time Frame: Day 1 to Post-discharge (6 months) ]

14.  Secondary:   Tolerability of Diuretic Therapy   [ Time Frame: Day 1 until Discharge (participants will be followed for the duration of hospital stay, an expected average of 2 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the small sample size, data was not able to be analyzed.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Office of Clinical Trials
Organization: NYU Langone Medical Center
phone: 646-754-7431
e-mail: clinicaltrials@nyumc.org



Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01890694     History of Changes
Other Study ID Numbers: 10-02496
First Submitted: June 20, 2012
First Posted: July 2, 2013
Results First Submitted: March 10, 2016
Results First Posted: April 11, 2016
Last Update Posted: December 11, 2017