At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 615 enrolled
Drug / intervention
Pregabalin +3 moredrug
Likely dose
Pregabalin 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Feb 27, 2008·Updated Jan 28, 2021
In Brief
A Phase 4 clinical trial evaluating Pregabalin, Lorazepam, and 1 other intervention for Generalized Anxiety Disorder. Completed, enrolled 615 participants across 57 sites in 16 countries.
Detailed Summary
The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Anxiety Disorder
CountriesArgentina, Austria, Costa Rica, Croatia, Czechia, Finland, Greece, India, Indonesia, Lithuania, Mexico, Russia, Serbia, Slovenia, Spain, Turkey (Türkiye)
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2008
Enrollment StartMay 2009
Primary CompletionApr 2012
TodayJul 2026
First PostedFeb 27, 2008
Enrollment StartMay 1, 2009
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 18.3 years ago
Interventions
Pregabalindrug
Pregabalin 150-300 mg given twice a day
Lorazepamdrug
Lorazepam 3-4 mg given twice a day
Pregabalindrug
Pregabalin 450-600 mg given twice a day
Placebodrug
Placebo