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NCT00090311 · ClinicalTrials.gov registry record · Phase 3

Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
220
Enrollment target

NCT00090311: Completed Phase 3 study, sponsored by AstraZeneca.

NCT00090311 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 220 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00090311, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
220 participants
Enrollment target

Study Summary

The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.

Interventions

  • DRUG quetiapine fumarate

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2004-07
Est. Completion 2006-07
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT00090311 record still lists

NCT00090311 is an interventional study that assigns participants to a tested intervention. The registered 220 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 (72% lower).

The record links to 0 conditions, and to 1 intervention - of which quetiapine fumarate is the first listed.

NCT00090311 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00090311 about?

NCT00090311 is a clinical study titled "Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania". The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.

What is the current status of trial NCT00090311?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2004-07. Estimated completion is 2006-07.

What interventions are being tested in trial NCT00090311?

The interventions under investigation include: quetiapine fumarate (DRUG).

Who is sponsoring clinical trial NCT00090311?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00090311's enrollment target sits among peer trials

220 1318th of 2000 higher than 672 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 NCT00090311, the US trial registry maintained by the National Library of Medicine. NCT00090311 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.