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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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 447 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00422123
The ClinicalTrials.gov registry entry for NCT00422123 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 447 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Quetiapine fumarate (Seroquel) SR is the first listed.
NCT00422123 reports 0 study locations.
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.
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