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NCT00422123 · ClinicalTrials.gov registry record · Phase 3
Phase 3 /Seroquel SR Acute Mania Monotherapy - US
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 447
- Enrollment target
NCT00422123: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00422123 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 447 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00422123, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 447 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Interventions
- DRUG Quetiapine fumarate (Seroquel) SR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2007-01 |
| Est. Completion | 2007-07 |
| Phase | Phase 3 |
What the finished NCT00422123 record still lists
NCT00422123 is an interventional study that assigns participants to a tested intervention. The registered 447 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 (42% lower).
The record links to 0 conditions, and to 1 intervention - of which Quetiapine fumarate (Seroquel) SR is the first listed.
NCT00422123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00422123 about?
NCT00422123 is a clinical study titled "Phase 3 /Seroquel SR Acute Mania Monotherapy - US". The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR afte...
What is the current status of trial NCT00422123?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2007-01. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00422123?
The interventions under investigation include: Quetiapine fumarate (Seroquel) SR (DRUG).
Who is sponsoring clinical trial NCT00422123?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00422123's enrollment target sits among peer trials
447 864th of 2000 higher than 1,137 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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