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A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)

Trial Profile

A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2019

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At a glance

  • Drugs Ziprasidone (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Pfizer
  • Most Recent Events

    • 24 Sep 2019 Planned End Date changed from 5 Oct 2020 to 6 Jan 2021.
    • 24 Sep 2019 Planned primary completion date changed from 3 Sep 2020 to 30 Nov 2020.
    • 19 Mar 2019 Planned number of patients changed from 180 to 194.
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