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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
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Tolvaptan
Hide Arm/Group Description Subjects will receive placebo once daily. Subjects will receive 15 mg Tolvaptan once daily.
Period Title: Overall Study
Started 1 1
Completed 0 0
Not Completed 1 1
Arm/Group Title Placebo Tolvaptan Total
Hide Arm/Group Description Subjects will receive placebo once daily. Subjects will receive 15 mg Tolvaptan once daily. Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
2
 100.0%
1.Primary Outcome
Title Length of Hospital Stay
Hide Description Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Time Frame participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected due to premature termination of the trial
Arm/Group Title Placebo Tolvaptan
Hide Arm/Group Description:
Subjects will receive placebo once daily.
Subjects will receive 15 mg Tolvaptan once daily.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Severity of Hepatic Encephalopathy
Hide Description Change from baseline of Hepatic Encephalopathy
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Severity of Hepatic Encephalopathy
Hide Description Change from baseline of Hepatic Encephalopathy
Time Frame Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Severity of Hepatic Encephalopathy
Hide Description Change from baseline of Hepatic Encephalopathy
Time Frame Day 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Severity of Hepatic Encephalopathy
Hide Description Change from baseline of Hepatic Encephalopathy
Time Frame Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Severity of Hepatic Encephalopathy
Hide Description Change from baseline of Hepatic Encephalopathy
Time Frame participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Severity of Hepatic Encephalopathy
Hide Description Change from baseline of Hepatic Encephalopathy
Time Frame Week 1-4 Post-discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Severity of Hepatic Encephalopathy
Hide Description Change from baseline of Hepatic Encephalopathy
Time Frame Months 2-6 post-discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Ascites
Hide Description Improved control of ascites
Time Frame Day 1 to Post-discharge (6 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Renal Function [BUN and Creatinine Laboratory Results]
Hide Description Improved renal function from baseline
Time Frame Day 1 to Post-discharge (6 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Hospital Readmission Rate
Hide Description Lower readmission rate
Time Frame Post-Discharge (6 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Survival
Hide Description Improved chances of survival when receiving Tolvaptan vs. standard of care
Time Frame Post-discharge (6 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Neutrophil Function [Results From the Assay of Neutrophils]
Hide Description Improved neutrophil function from baseline
Time Frame Day 1 to Post-discharge (6 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Tolerability of Diuretic Therapy
Hide Description Improved ability to tolerate diuretic therapy, as evidenced by reduced adverse events to diuretic therapy and reduced risk of re-hospitalization.
Time Frame Day 1 until Discharge (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Arm/Group Title Tolvaptan Placebo
Hide Arm/Group Description:
Subjects will receive Tolvaptan once daily.
Study Terminated. No data analyzed
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Tolvaptan
Hide Arm/Group Description Subjects will receive placebo once daily. Subjects will receive 15 mg Tolvaptan once daily.
All-Cause Mortality
Placebo Tolvaptan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Tolvaptan
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Tolvaptan
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Due to the small sample size, data was not able to be analyzed.
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
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