Status:
COMPLETED
Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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).
Eligibility Criteria
Inclusion
- Diagnosis Generalized Anxiety Disorder
- HAM-A score \>=18 and HAM-D (item 1) score \>=2 at screening and baseline
- Needs pharmacological treatment
Exclusion
- Current or past diagnosis of any other DSM IV Axis I disorders
- A history of failed treatment with a benzodiazepine
- Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
615 Patients enrolled
Trial Details
Trial ID
NCT00624780
Start Date
May 1 2009
End Date
April 1 2012
Last Update
January 28 2021
Active Locations (57)
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1
Pfizer Investigational Site
La Plata, Buenos Aires, Argentina, B1904ADM
2
Pfizer Investigational Site
Lanús, Prov. de Buenos Aires, Argentina, B1824IBR
3
Pfizer Investigational Site
Buenos Aires, Argentina, C1115AAJ
4
Pfizer Investigational Site
Buenos Aires, Argentina, C1405BOA