Study of Ascending Levels of Tolvaptan in Hyponatremia

Study acronym: SALT2
StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Minor Primary completion date: Jul 1, 2005v8 Show 7 more changesShow less
    • Study completion date: Jul 2005 to Jul 1, 2005
    • Start date: Nov 2003 to Nov 1, 2003
    • Interventions: Tolvaptan (Drug) to Placebo (Drug), Tolvaptan (Drug)
    • Eligibility criteria expanded, about 8 words
    • Study arms: 0 to 2
    • Study description shortened, about 4 words
    • Study title shortened, about 2 words
  2. 2 versions Re-verified since Sep 2, 2008, no change to tracked fieldsv6-v7
  3. Minor Trial status: Active, Not Recruiting to Completedv5
  4. Re-verified, no change to tracked fieldsv4
  5. Notable Primary endpoints revised (3)
    • Secondary endpoints revised (3)
    v3
  6. Minor Eligibility criteria revisedv2
  7. 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.
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The purpose of this study was 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 NCT00201994
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Otsuka Pharmaceutical Co., Ltd.
Conditions
(from sponsor)
Hyponatremia
Related terms Diabetes Insipidus, Fibrosis, Heart Failure, Hyponatremia, Inappropriate ADH Syndrome
Enrollment 243 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov