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NCT00265330 · ClinicalTrials.gov registry record · Phase 3

Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

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

Completed
Registry status
Phase 3
Development phase
169
Enrollment target

NCT00265330: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

NCT00265330 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 169 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00265330, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

COMPLETED
Registry status
Phase 3
Development phase
169 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)

Primary Outcome

YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.

Interventions

  • DRUG Ziprasidone oral capsules

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2006-03
Est. Completion 2008-01
Phase Phase 3

What the finished NCT00265330 record still lists

NCT00265330 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 1 intervention - of which Ziprasidone oral capsules is the first listed.

NCT00265330 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00265330 about?

NCT00265330 is a clinical study titled "Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)". The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)

What is the current status of trial NCT00265330?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2006-03. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00265330?

The interventions under investigation include: Ziprasidone oral capsules (DRUG).

Who is sponsoring clinical trial NCT00265330?

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.

How this trial's enrollment target compares

Where NCT00265330's enrollment target sits among peer trials

169 1459th of 2000 higher than 542 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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Source: ClinicalTrials.gov NCT00265330, the US trial registry maintained by the National Library of Medicine. NCT00265330 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.