Generalized Anxiety DisorderPhase 3NCT00735267
A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)
A Phase 3 study testing PD 0332334 in people with Generalized Anxiety Disorder, run by Pfizer at 93 sites in United States.
Trial summary
This 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- PD 0332334
- Type of treatment
- Pill or oral medicine
- How many people
- 468 participants
- Where
- 93 sitesUnited States
- Study dates
- Oct 2008to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
93 sites in 1 country.
93 sites in 1 country
United States93 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87109
Pfizer Investigational Site
Allentown, Pennsylvania, 18104
Pfizer Investigational Site
Altamonte Springs, Florida, 32701
Pfizer Investigational Site
Arcadia, California, 91007-3462
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Austin, Texas, 78756
Pfizer Investigational Site
Baltimore, Maryland, 21208
Pfizer Investigational Site
Belmont, Massachusetts, 02478
Pfizer Investigational Site
Bethany, Oklahoma, 73008
Pfizer Investigational Site
Beverly Hills, California, 90210
Pfizer Investigational Site
Birmingham, Alabama, 35226
Pfizer Investigational Site
Boston, Massachusetts, 02135
Pfizer Investigational Site
Brooklyn, New York, 11235
Pfizer Investigational Site
Charlottesville, Virginia, 22903
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Costa Mesa, California, 92626
Pfizer Investigational Site
Costa Mesa, California, 92627
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Dayton, Ohio, 45408
Pfizer Investigational Site
Denver, Colorado, 80239
Pfizer Investigational Site
DeSoto, Texas, 75115
Pfizer Investigational Site
Encino, California, 91316
Pfizer Investigational Site
Escondido, California, 92025
Pfizer Investigational Site
Fall River, Massachusetts, 02721
Pfizer Investigational Site
Fort Myers, Florida, 33912
Pfizer Investigational Site
Greenwood, Indiana, 46143
Pfizer Investigational Site
Hamden, Connecticut, 06518
Pfizer Investigational Site
Haverhill, Massachusetts, 01830
Pfizer Investigational Site
Houston, Texas, 77008
Pfizer Investigational Site
Houston, Texas, 77074
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Lake Charles, Louisiana, 70601
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Libertyville, Illinois, 60048
Pfizer Investigational Site
Lincoln, Rhode Island, 02865
Pfizer Investigational Site
Litchfield Park, Arizona, 85340
Pfizer Investigational Site
Maitland, Florida, 32751
Pfizer Investigational Site
Marietta, Georgia, 30060
Pfizer Investigational Site
Media, Pennsylvania, 19063
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Memphis, Tennessee, 38134
Pfizer Investigational Site
Miami, Florida, 33126
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Middleton, Wisconsin, 53562
Pfizer Investigational Site
Murrieta, California, 92562
Pfizer Investigational Site
Naperville, Illinois, 60563
Pfizer Investigational Site
Nashua, New Hampshire, 03060
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
New York, New York, 10023
Pfizer Investigational Site
New York, New York, 10024
Pfizer Investigational Site
New York, New York, 10128-1708
Pfizer Investigational Site
Newport Beach, California, 92660-2452
Pfizer Investigational Site
Norristown, Pennsylvania, 19401
Pfizer Investigational Site
Norwich, Connecticut, 06360
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73103
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73116
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Orange City, Florida, 32763
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Owensboro, Kentucky, 42301
Pfizer Investigational Site
Park Ridge, Illinois, 60068
Pfizer Investigational Site
Pasadena, California, 91106
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19139
Pfizer Investigational Site
Pittsfield, Massachusetts, 01201
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Prairie Village, Kansas, 66206
Pfizer Investigational Site
Raleigh, North Carolina, 27607
Pfizer Investigational Site
Redlands, California, 92374
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Salem, Oregon, 97301
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Sherman Oaks, California, 91403
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
Temecula, California, 92591
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
The Bronx, New York, 10467
Pfizer Investigational Site
Toledo, Ohio, 43609
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Upland, California, 91786
Pfizer Investigational Site
Waukesha, Wisconsin, 53188-1660
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
Wichita, Kansas, 67207
Pfizer Investigational Site
Wildomar, California, 92595
Pfizer Investigational Site
Woodstock, Vermont, 05091
About this study
Official title: A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder
This 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.
Read the detailed description
Termination 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- PD 0332334
- Keywords
- Generalized Anxiety Disorder
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD 0332334Drug
Also called imagabalin
Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year
What is being measured
The primary outcome is the main question the study is designed to answer.
The nature, incidence, and duration of adverse events monitored throughout the study by physical exam
Measured: Screening, Wk 25 & Wk 52/EOT
Electrocardiogram will be performed at screening and during follow up visits to assess the safety and tolerability of the compound in terms of clinically significant cardiovascular changes
Measured: Screening, Wk 4, Wk 25, Wk 52/EOT
The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events
Measured: As needed
The nature, incidence, and duration of adverse events monitored throughout the study by vital signs evaluation at each visit, weight measurements and clinical laboratory monitoring periodically
Measured: Screening, Baseline, Wk 4, Wk 12, Wk 25, Wk 38, & Wk 52/EOT
All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound
Measured: Weekly
Secondary outcomes (3)
The Hamilton Rating Scale for Anxiety (HAM-A) will be used to assess symptoms of Generalized Anxiety Disorder (GAD) over a one year time period.
Measured: Baseline, Wk 12, Wk 25, Wk 38, Wk 51 & Wk 52/EOT
The Clinical Global Impression of Severity (CGI-S), and the Daily Diary (DD) will also be used to assess symptoms of GAD over a one year time period.
Measured: Baseline, Wk 51 & Wk 52/EOT
The Health Care Utilization Questionnaire will be utilized to assess overall Health Care over a one year time period.
Measured: Baseline, Wk 12, Wk 25, Wk 38 & Wk 51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Please see Detailed Description for termination reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735267
- Sponsor's protocol ID
- A5361022
- Status last verified
- Nov 2012
- First submitted
- 12 Aug 2008
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00735267
- Acronym / sponsor ID
- A5361022
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please see Detailed Description for termination reason.
- Enrolment
- 468 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 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 description
Termination 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD 0332334Also: imagabalinDosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year | Drug | – |
Primary outcome
The nature, incidence, and duration of adverse events monitored throughout the study by physical exam
Time frame: Screening, Wk 25 & Wk 52/EOT
Electrocardiogram will be performed at screening and during follow up visits to assess the safety and tolerability of the compound in terms of clinically significant cardiovascular changes
Time frame: Screening, Wk 4, Wk 25, Wk 52/EOT
The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events
Time frame: As needed
The nature, incidence, and duration of adverse events monitored throughout the study by vital signs evaluation at each visit, weight measurements and clinical laboratory monitoring periodically
Time frame: Screening, Baseline, Wk 4, Wk 12, Wk 25, Wk 38, & Wk 52/EOT
All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound
Time frame: Weekly
3 secondary outcomes
The Hamilton Rating Scale for Anxiety (HAM-A) will be used to assess symptoms of Generalized Anxiety Disorder (GAD) over a one year time period.
Time frame: Baseline, Wk 12, Wk 25, Wk 38, Wk 51 & Wk 52/EOT
The Clinical Global Impression of Severity (CGI-S), and the Daily Diary (DD) will also be used to assess symptoms of GAD over a one year time period.
Time frame: Baseline, Wk 51 & Wk 52/EOT
The Health Care Utilization Questionnaire will be utilized to assess overall Health Care over a one year time period.
Time frame: Baseline, Wk 12, Wk 25, Wk 38 & Wk 51
Results and safety
The study was stopped early (reason given: Please see Detailed Description for termination reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
93 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PD 0332334 in people with Generalized Anxiety Disorder, run by Pfizer at 93 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Please see Detailed Description for termination reason.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The nature, incidence, and duration of adverse events monitored throughout the study by physical exam (time frame: Screening, Wk 25 & Wk 52/EOT). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2012; AzTrials last refreshed its copy on 6 Nov 2026.