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

Primary Purpose

Anxiety

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pregabalin
Venlafaxine XR
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2005
Last Updated
January 20, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00151450
Brief Title
Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
390 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Type
Drug
Intervention Name(s)
Venlafaxine XR
Primary Outcome Measure Information:
Title
Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
De Pinte
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Ghent
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Waregem
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Gatineau
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saint-Jean-Sur-Richelieu
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Angouleme
Country
France
Facility Name
Pfizer Investigational Site
City
Arcachon
Country
France
Facility Name
Pfizer Investigational Site
City
Bully Les Mines
Country
France
Facility Name
Pfizer Investigational Site
City
Cherbourg
Country
France
Facility Name
Pfizer Investigational Site
City
Elancourt
Country
France
Facility Name
Pfizer Investigational Site
City
Orvault
Country
France
Facility Name
Pfizer Investigational Site
City
Rennes
Country
France
Facility Name
Pfizer Investigational Site
City
Saint-andre-de-cubzac
Country
France
Facility Name
Pfizer Investigational Site
City
Savigny Sur Orge
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg
Country
France
Facility Name
Pfizer Investigational Site
City
Versailles
Country
France
Facility Name
Pfizer Investigational Site
City
Bray
State/Province
County Wicklow
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Vicenza
State/Province
Bassano DEL Grappa
Country
Italy
Facility Name
Pfizer Investigational Site
City
Citta' Di Castello
State/Province
Perugia
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catania
Country
Italy
Facility Name
Pfizer Investigational Site
City
Sassari
Country
Italy
Facility Name
Pfizer Investigational Site
City
Wildervank
State/Province
GR
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Hoogvliet
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Huizen
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Losser
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Musselkanaal
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Oude Pekela
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Langreo
State/Province
Asturias
Country
Spain
Facility Name
Pfizer Investigational Site
City
VIC
State/Province
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Alcala de Henares
State/Province
Madrid
Country
Spain
Facility Name
Pfizer Investigational Site
City
Gandia
State/Province
Valencia
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
Country
Spain
Facility Name
Pfizer Investigational Site
City
Salamanca
Country
Spain
Facility Name
Pfizer Investigational Site
City
Zamora
Country
Spain
Facility Name
Pfizer Investigational Site
City
Göteborg
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Linkoping
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lund
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Malmö
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Sundsvall
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Trollhattan
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21456104
Citation
Kasper S, Herman B, Nivoli G, Van Ameringen M, Petralia A, Mandel FS, Baldinetti F, Bandelow B. Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial. Int Clin Psychopharmacol. 2009 Mar;24(2):87-96. doi: 10.1097/yic.0b013e32831d7980.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081012&StudyName=Comparison+of+Pregabalin+versus+Venlafaxine+XR+and+Placebo+in+the+Treatment+of+Generalized+Anxiety+Disorder
Description
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Learn more about this trial

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

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