Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia (SALACIA)

This study has been terminated.
(Recruitment challenges and results of interim futility analysis, which showed less than likely to achieve primary endpoint goal-length of hospital stay.)
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01227512
First received: October 22, 2010
Last updated: October 21, 2014
Last verified: October 2014
Results First Received: May 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Hyponatremia
Dilutional Hyponatremia
Inappropriate ADH Syndrome
Interventions: Drug: tolvaptan
Other: Fluid Restriction

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 191 participants were recruited at 81 study sites in the United States (US). A total of 124 participants were randomised to treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants randomized 1:1 to tolvaptan (15 mg/day,titrated to 30 mg/day or 60 mg/day) without fluid restriction or placebo with titrated fluid restriction (500 to 1500 mL/day). Stratified based on severity of baseline symptoms (3-4, or 5-6 on the Clinical Global Impression of Severity and study center. All partipants were blinded to treatment.

Reporting Groups
  Description
Tolvaptan 15-60 mg/Day Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
Placebo Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.

Participant Flow:   Overall Study
    Tolvaptan 15-60 mg/Day     Placebo  
STARTED     66     58  
COMPLETED     53     48  
NOT COMPLETED     13     10  
Physician Decision                 6                 6  
Adverse Event                 4                 3  
Withdrawal by Subject                 3                 0  
Participant met withdrawal criteria                 0                 1  



  Baseline Characteristics
  Hide 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
Tolvaptan 15-60 mg/Day Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
Placebo Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
Total Total of all reporting groups

Baseline Measures
    Tolvaptan 15-60 mg/Day     Placebo     Total  
Number of Participants  
[units: participants]
  66     58     124  
Age  
[units: Years]
Mean ± Standard Deviation
  65.7  ± 15.8     67.7  ± 15.6     66.7  ± 15.7  
Gender  
[units: participants]
     
Female     29     34     63  
Male     37     24     61  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Length of Hospital Stay (LoS)   [ Time Frame: 45 days ]

2.  Secondary:   Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms.   [ Time Frame: Baseline to 48 hours post dose ]

3.  Secondary:   Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms.   [ Time Frame: Baseline to 24 and 72 hours post dose ]

4.  Secondary:   Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms.   [ Time Frame: Baseline to 48 hours post dose ]

5.  Secondary:   Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]).   [ Time Frame: 0 to 72 hours ]

6.  Secondary:   Time to First 2-point Improvement in CGI-S Score.   [ Time Frame: Up to 72 hours ]

7.  Secondary:   Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2.   [ Time Frame: 48 hours post dose ]

8.  Secondary:   Percentage of Participants Requiring Rescue Therapy for Hyponatremia   [ Time Frame: 7 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
phone: 800 562-3974


No publications provided


Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01227512     History of Changes
Other Study ID Numbers: 156-08-275
Study First Received: October 22, 2010
Results First Received: May 29, 2014
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration