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A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

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NCT00921063

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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

- Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD)
(Diagnostic and Statistical Manual-IV [DSM-IV], 300.02).

- HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both
Screening and Baseline/Randomization.

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

- Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive
Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia;
Caffeine-induced anxiety disorder;

- Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder;
Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder;
Dissociative Disorders; Antisocial or borderline personality disorder

- Current use of psychotropic medications (i.e., drugs normally prescribed for
depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2
weeks prior to dosing.

NCT00921063
Pfizer
Completed
A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

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A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 5-Week Trial To Assess The Efficacy And Safety Of PD 0332334 Compared To Placebo And Alprazolam Extended-Release In Patients With Generalized Anxiety Disorder
The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Drug: PD 0332334
    250 mg capsule, BID for 4 weeks
    Other Name: imagabalin
  • Drug: PD 0332334
    100 mg capsule, BID for 4 weeks
  • Drug: placebo
    0 mg capsule, BID for 4 weeks
  • Drug: Alprazolam extended release
    1 mg capsule, BID for 4 weeks
    Other Name: Xanax XR
  • Experimental: PD 0332334 250 mg
    Intervention: Drug: PD 0332334
  • Experimental: PD 0332334 100 mg
    Intervention: Drug: PD 0332334
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: Alprazolam extended release
    Intervention: Drug: Alprazolam extended release
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
July 2006
July 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02).
  • HAM-A Total Score ?20 and item #1 on the HAM-D (depressed mood score) ?2 at both Screening and Baseline/Randomization.

Exclusion Criteria:

  • Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
  • Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
  • Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00921063
A5361007
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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