Safety and Efficacy maintenance study of quetiapine SR to treat GAD patients. - PLATINUM

Study identifier:D1448C00012

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multi-centre,Double-blind,Randomised-Withdrawal,Parallel-group, Placebo-controlled Phase III Study of the Efficacy and Safety of Quetiapine SR as Monotherapy in the Maintenance Treatment of Patients with GAD Following an Open-Label Stabilisation Period

Medical condition

Anxiety Disorders

Phase

Phase 3

Healthy volunteers

Study drug

Quetiapine SR

Sex

All

Actual Enrollment

575

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Mar 2006

Primary Completion Date: -

Study Completion Date: 01 Aug 2007

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Owensboro, KY, United States

Location

Research Site

Brisbane, QLD, Australia

Location

Research Site

WEST BURLEIGH, QLD, Australia

Location

Research Site

Everton Park, QLD, Australia

Location

Research Site

Malvern, VIC, Australia

Location

Research Site

Edmonton, AB, Canada

Location

Research Site

Bathurst, NB, Canada

Location

Research Site

Hamilton, ON, Canada

Arms	Assigned Interventions

Documents available

AstraZeneca Clinical Trial Information – Outside US
Download
https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1792&filename=CSR-D1448C00012.pdf
Download
CSR-D1448C00012.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Martin Brecher

AstraZeneca

Safety and Efficacy maintenance study of quetiapine SR to treat GAD patients. - PLATINUM

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

AstraZeneca Clinical Trial Information – Outside US

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1792&filename=CSR-D1448C00012.pdf

CSR-D1448C00012.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator