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NCT00389064 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
450
Enrollment target

NCT00389064: Completed Phase 3 study, sponsored by AstraZeneca.

NCT00389064 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 450 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.

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The verdict

NCT00389064, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
450 participants
Enrollment target

Study Summary

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder. PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Primary Outcome

HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization

Interventions

  • DRUG Placebo
  • DRUG Quetiapine XR

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2006-09
Est. Completion 2008-04
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT00389064 record still lists

NCT00389064 is an interventional study that assigns participants to a tested intervention. The registered 450 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 2 interventions - of which Placebo is the first listed.

NCT00389064 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00389064 about?

NCT00389064 is a clinical study titled "Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder". The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder. PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the s...

What is the current status of trial NCT00389064?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2006-09. Estimated completion is 2008-04.

What interventions are being tested in trial NCT00389064?

The interventions under investigation include: Placebo (DRUG), Quetiapine XR (DRUG).

Who is sponsoring clinical trial NCT00389064?

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 NCT00389064's enrollment target sits among peer trials

450 837th 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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Source: ClinicalTrials.gov NCT00389064, the US trial registry maintained by the National Library of Medicine. NCT00389064 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.