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"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Enrollment target: 240 to 205 Primary completion date: Dec 1, 2005 · Completion date: Feb 2006 to Dec 1, 2005 · Start date: Apr 2003 to Apr 1, 2003 · 5 morev6 Show 8 more changesShow less
    • Primary completion date: Dec 1, 2005
    • Completion date: Feb 2006 to Dec 1, 2005
    • Start date: Apr 2003 to Apr 1, 2003
    • Interventions: tolvaptan (Drug) to placebo matching tolvaptan (Drug), tolvaptan (Drug)
    • Eligibility criteria expanded, about 10 words
    • Study sites revised (23)
    • Study arms: 0 to 2
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Primary endpoints revised (2) Trial status: Active, Not Recruiting to Completed · Secondary endpoints revised (17)v4 Show 2 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Secondary endpoints revised (17)

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Trial status: Recruiting to Active, Not Recruiting Study sites revised (23)v3 Show 1 more changeShow less
  5. Notable Trial status: Not Yet Recruiting to Recruiting Enrollment target: 240 · Study sites: 9 to 23 · Completion date: Feb 2006 · 5 morev2 Show 8 more changesShow less
    • Enrollment target: 240
    • Study sites: 9 to 23
    • Completion date: Feb 2006
    • Start date: Apr 2003
    • Eligibility criteria expanded, about 336 words
    • Study description expanded, about 336 words
    • Collaborators expanded, about 4 words
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study's purpose is to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal, and to characterize and quantify the potential clinical benefits of this treatment.
Trial Details
NCT Number NCT00072683
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Otsuka Pharmaceutical Co., Ltd.
Conditions Hyponatremias, Water Intoxication, Inappropriate ADH Syndrome, Water-Electrolyte Imbalances
Enrollment 205 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov