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NCT00534599 · ClinicalTrials.gov registry record · Phase 3
Generalized Anxiety Disorder Adjunct Study
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 409
- Enrollment target
NCT00534599: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00534599 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 409 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00534599, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 409 participants
- Enrollment target
Study Summary
This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo
Primary Outcome
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.
Interventions
- DRUG Placebo
- DRUG quetiapine fumarate XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 409 participants |
| Start Date | 2007-08 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
What the finished NCT00534599 record still lists
NCT00534599 is an interventional study that assigns participants to a tested intervention. The registered 409 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 (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00534599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00534599 about?
NCT00534599 is a clinical study titled "Generalized Anxiety Disorder Adjunct Study". This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in pa...
What is the current status of trial NCT00534599?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 409 participants. The study started on 2007-08. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00534599?
The interventions under investigation include: Placebo (DRUG), quetiapine fumarate XR (DRUG).
Who is sponsoring clinical trial NCT00534599?
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 NCT00534599's enrollment target sits among peer trials
409 911th of 2000 higher than 1,090 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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