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

NCT00735267 | Terminated Phase 3

• 1 other identifier: A5361022
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 93

Brief 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.

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (5)

• The nature, incidence, and duration of adverse events monitored throughout the study by physical exam

  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

  Screening, Wk 4, Wk 25, Wk 52/EOT

• The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events

  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

  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

  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.

  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.

  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.

  Baseline, Wk 12, Wk 25, Wk 38 & Wk 51

Interventions

PD 0332334 DRUG

Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year

Also known as: imagabalin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (93)

Pfizer Investigational Site

Birmingham, Alabama, 35226, United States

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Litchfield Park, Arizona, 85340, United States

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Arcadia, California, 91007-3462, United States

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Beverly Hills, California, 90210, United States

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Costa Mesa, California, 92626, United States

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Costa Mesa, California, 92627, United States

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Encino, California, 91316, United States

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Escondido, California, 92025, United States

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Murrieta, California, 92562, United States

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National City, California, 91950, United States

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Newport Beach, California, 92660-2452, United States

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Orange, California, 92868, United States

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Pasadena, California, 91106, United States

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Redlands, California, 92374, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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Sherman Oaks, California, 91403, United States

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Temecula, California, 92591, United States

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Upland, California, 91786, United States

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Wildomar, California, 92595, United States

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Denver, Colorado, 80239, United States

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Hamden, Connecticut, 06518, United States

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Norwich, Connecticut, 06360, United States

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Altamonte Springs, Florida, 32701, United States

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Fort Myers, Florida, 33912, United States

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Jacksonville, Florida, 32216, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33143, United States

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Orange City, Florida, 32763, United States

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Orlando, Florida, 32806, United States

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South Miami, Florida, 33143, United States

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West Palm Beach, Florida, 33407, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30328, United States

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Marietta, Georgia, 30060, United States

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Libertyville, Illinois, 60048, United States

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Naperville, Illinois, 60563, United States

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Park Ridge, Illinois, 60068, United States

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Greenwood, Indiana, 46143, United States

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Terre Haute, Indiana, 47802, United States

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Overland Park, Kansas, 66212, United States

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Prairie Village, Kansas, 66206, United States

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Wichita, Kansas, 67207, United States

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Owensboro, Kentucky, 42301, United States

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Lake Charles, Louisiana, 70601, United States

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Baltimore, Maryland, 21208, United States

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Belmont, Massachusetts, 02478, United States

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Boston, Massachusetts, 02135, United States

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Fall River, Massachusetts, 02721, United States

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Haverhill, Massachusetts, 01830, United States

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Pittsfield, Massachusetts, 01201, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89146, United States

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Nashua, New Hampshire, 03060, United States

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Albuquerque, New Mexico, 87109, United States

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Brooklyn, New York, 11235, United States

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New York, New York, 10023, United States

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New York, New York, 10024, United States

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New York, New York, 10128-1708, United States

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Rochester, New York, 14618, United States

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The Bronx, New York, 10467, United States

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Raleigh, North Carolina, 27607, United States

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Columbus, Ohio, 43210, United States

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Dayton, Ohio, 45408, United States

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Toledo, Ohio, 43609, United States

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Toledo, Ohio, 43623, United States

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Bethany, Oklahoma, 73008, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73116, United States

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Portland, Oregon, 97210, United States

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Salem, Oregon, 97301, United States

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Allentown, Pennsylvania, 18104, United States

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Media, Pennsylvania, 19063, United States

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Norristown, Pennsylvania, 19401, United States

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Philadelphia, Pennsylvania, 19139, United States

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Lincoln, Rhode Island, 02865, United States

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Columbia, South Carolina, 29201, United States

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Memphis, Tennessee, 38119, United States

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Memphis, Tennessee, 38134, United States

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Austin, Texas, 78756, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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DeSoto, Texas, 75115, United States

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Houston, Texas, 77008, United States

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Houston, Texas, 77074, United States

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Lake Jackson, Texas, 77566, United States

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San Antonio, Texas, 78229, United States

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Woodstock, Vermont, 05091, United States

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Charlottesville, Virginia, 22903, United States

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Seattle, Washington, 98104, United States

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Middleton, Wisconsin, 53562, United States

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Waukesha, Wisconsin, 53188-1660, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

imagabalin

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

US (93)