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Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

Last updated on December 16, 2017

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Study Location
Pfizer Investigational Site
La Plata, Buenos Aires, B1904ADM Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis Generalized Anxiety Disorder

- HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline

- Needs pharmacological treatment

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00624780
Pfizer
Completed
Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

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Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder
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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Drug: Pregabalin
    Pregabalin 150-300 mg given twice a day
    Other Name: Lyrica
  • Drug: Lorazepam
    Lorazepam 3-4 mg given twice a day
  • Drug: Pregabalin
    Pregabalin 450-600 mg given twice a day
    Other Name: Lyrica
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: Pregabalin
  • Active Comparator: 2
    Intervention: Drug: Lorazepam
  • Experimental: 3
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
615
April 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis Generalized Anxiety Disorder
  • HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline
  • Needs pharmacological treatment

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Costa Rica,   Croatia,   Czech Republic,   Finland,   Greece,   India,   Indonesia,   Lithuania,   Mexico,   Russian Federation,   Serbia,   Slovenia,   Spain,   Turkey
Colombia
 
NCT00624780
A0081147
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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