Who is sponsoring NCT00389064?

NCT00389064 is sponsored by AstraZeneca.

What condition does NCT00389064 study?

NCT00389064 studies Anxiety Disorders.

What drugs are being tested in NCT00389064?

Interventions: Quetiapine XR, Placebo.

What is the status of NCT00389064?

NCT00389064 is currently COMPLETED.

Last reviewed 2012-03-30 · How we verify

A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Generalised Anxiety Disorder

NCT00389064 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	450
Start date	2006-09
Completion	2008-04

Conditions

Anxiety Disorders

Interventions

Quetiapine XR
Placebo

Primary outcomes

Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score — Randomization to Week 9
HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization

Countries

United States, Estonia, Poland, Russia, Ukraine