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NCT03768726 · ClinicalTrials.gov registry record · Phase 3

Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder

A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

Terminated
Registry status
Phase 3
Development phase
23
Enrollment target

NCT03768726 is a Phase 3 study that was terminated before completion, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 23 participants.

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The verdict

NCT03768726, a Phase 3 study, was terminated before completion, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

TERMINATED
Registry status
Phase 3
Development phase
23 participants
Enrollment target

Study Summary

This 26-week open-label extension study is designed to provide information on the safety and tolerability of oral ziprasidone (20-80 mg BID (twice daily) with meals) during long-term administration in children and adolescents with Bipolar I Disorder (current or most recent episode manic).

Interventions

  • DRUG Placebo
  • DRUG Ziprasidone

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2018-12-21
Est. Completion 2020-07-31
Phase Phase 3

What the Registry Record Tells You About NCT03768726

The ClinicalTrials.gov registry entry for NCT03768726 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03768726 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03768726 about?

NCT03768726 is a clinical study titled "Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder". This 26-week open-label extension study is designed to provide information on the safety and tolerability of oral ziprasidone (20-80 mg BID (twice daily) with meals) during long-term administration in children and adolescents with Bipolar I Disorder (current or most recent episode manic).

What is the current status of trial NCT03768726?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2018-12-21. Estimated completion is 2020-07-31.

What interventions are being tested in trial NCT03768726?

The interventions under investigation include: Placebo (DRUG), Ziprasidone (DRUG).

Who is sponsoring clinical trial NCT03768726?

This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.