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

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Minor Enrollment target: 240 to 205v6 Show 8 more changesShow less
    • Primary completion date: Dec 1, 2005
    • Study 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
  2. 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
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (23)
    v3
  5. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Enrollment target: 240
    • Study sites: 9 to 23
    • Study 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
  6. Study First Submitted
  • 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
(from sponsor)
Hyponatremias, Water Intoxication, Inappropriate ADH Syndrome, Water-Electrolyte Imbalances
Related terms Diabetes Insipidus, Fibrosis, Hyponatremia, Inappropriate ADH Syndrome, Water Intoxication, Water-Electrolyte Imbalance
Enrollment 205 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov