You are here

A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)

Last updated on October 13, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35226 United States
Contact
1-800-718-1021
ClinicalTrials[email protected]
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

- Subjects must have completed all phases of one of the four preceding double-blind GAD
studies.

- Female must continue to use adequate birth control methods and have a negative serum
pregnancy test within 14 days prior to starting open label treatment.

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

- Subjects who experienced a serious adverse event during the preceding double-blind
efficacy study that was judged to be related to study medication by the investigator
or the sponsor's medical monitor.

- Individuals who have an ongoing, unresolved, clinically significant medical problem
that, in the judgment of the investigator or the sponsor's medical monitor, would
make it unsafe for the subject to participate in the study.

- Serious suicidal risk per the clinical investigators's judgement.

NCT00735267
Pfizer
Terminated
A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)
Official Title  ICMJE A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder
Brief SummaryThis study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD 0332334 administered in split dose (twice daily) in subjects with Generalized Anxiety Disorder.
Detailed DescriptionTermination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE Drug: PD 0332334
Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year
Other Name: imagabalin
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 20, 2009)
468
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2008)
760
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion DateApril 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have completed all phases of one of the four preceding double-blind GAD studies.
  • Female must continue to use adequate birth control methods and have a negative serum pregnancy test within 14 days prior to starting open label treatment.

Exclusion Criteria:

  • Subjects who experienced a serious adverse event during the preceding double-blind efficacy study that was judged to be related to study medication by the investigator or the sponsor's medical monitor.
  • Individuals who have an ongoing, unresolved, clinically significant medical problem that, in the judgment of the investigator or the sponsor's medical monitor, would make it unsafe for the subject to participate in the study.
  • Serious suicidal risk per the clinical investigators's judgement.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00735267
Other Study ID Numbers  ICMJE A5361022
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now