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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: Clinical Trial Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.
Interventions
- DRUG Placebo
- DRUG Ziprasidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 3 |
Why NCT03768726 stopped before completion
NCT03768726 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03768726 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03768726's enrollment target sits among peer trials
23 1952nd of 2000 higher than 48 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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