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NCT00151450 Clinical Trial

Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder

Anxiety Clinical Trial

Official title:
An 8-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Of Pregabalin (300-600 Mg/Day) And Venlafaxine XR (75-225 Mg/Day) For The Acute Treatment Of DSM-IV Generalized Anxiety Disorder In Outpatients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00151450
Other study ID # A0081012
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2005
Est. completion date November 2006

Study information
Verified date March 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.

Recruitment information / eligibility
Status Completed
Enrollment 390
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Male and female outpatients with diagnosis of generalized anxiety disorder. Exclusion Criteria: - Any serious or uncontrolled medical condition. - Current diagnosis of depression, dysthymia, obsessive-compulsive disorder.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin

• Venlafaxine XR

Locations
Country Name City State
Belgium Pfizer Investigational Site De Pinte
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Ghent
Belgium Pfizer Investigational Site Waregem
Canada Pfizer Investigational Site Gatineau Quebec
Canada Pfizer Investigational Site Hamilton Ontario
Canada Pfizer Investigational Site Kelowna British Columbia
Canada Pfizer Investigational Site Ottawa Ontario
Canada Pfizer Investigational Site Saint-Jean-Sur-Richelieu Quebec
France Pfizer Investigational Site Angouleme
France Pfizer Investigational Site Arcachon
France Pfizer Investigational Site Bully Les Mines
France Pfizer Investigational Site Cherbourg
France Pfizer Investigational Site Elancourt
France Pfizer Investigational Site Orvault
France Pfizer Investigational Site Rennes
France Pfizer Investigational Site Saint-andre-de-cubzac
France Pfizer Investigational Site Savigny Sur Orge
France Pfizer Investigational Site Strasbourg
France Pfizer Investigational Site Versailles
Ireland Pfizer Investigational Site Bray County Wicklow
Italy Pfizer Investigational Site Catania
Italy Pfizer Investigational Site Citta' Di Castello Perugia
Italy Pfizer Investigational Site Sassari
Italy Pfizer Investigational Site Vicenza Bassano DEL Grappa
Netherlands Pfizer Investigational Site Hoogvliet
Netherlands Pfizer Investigational Site Huizen
Netherlands Pfizer Investigational Site Losser
Netherlands Pfizer Investigational Site Musselkanaal
Netherlands Pfizer Investigational Site Oude Pekela
Netherlands Pfizer Investigational Site Wildervank GR
Spain Pfizer Investigational Site Alcala de Henares Madrid
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Gandia Valencia
Spain Pfizer Investigational Site Langreo Asturias
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Salamanca
Spain Pfizer Investigational Site VIC Barcelona
Spain Pfizer Investigational Site Zamora
Sweden Pfizer Investigational Site Göteborg
Sweden Pfizer Investigational Site Linkoping
Sweden Pfizer Investigational Site Lund
Sweden Pfizer Investigational Site Malmö
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Sundsvall
Sweden Pfizer Investigational Site Trollhattan

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Ireland,  Italy,  Netherlands,  Spain,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.
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