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NCT00735267 Clinical Trial

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

Generalized Anxiety Disorder Clinical Trial

Official title:
A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00735267
Other study ID # A5361022
Secondary ID
Status Terminated
Phase Phase 3
First received August 12, 2008
Last updated November 9, 2012
Start date October 2008
Est. completion date April 2009

Study information
Verified date November 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 468
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PD 0332334
Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year

Locations
Country Name City State
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Allentown Pennsylvania
United States Pfizer Investigational Site Altamonte Springs Florida
United States Pfizer Investigational Site Arcadia California
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Belmont Massachusetts
United States Pfizer Investigational Site Bethany Oklahoma
United States Pfizer Investigational Site Beverly Hills California
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Bronx New York
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Charlottesville Virginia
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Costa Mesa California
United States Pfizer Investigational Site Costa Mesa California
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site DeSoto Texas
United States Pfizer Investigational Site Encino California
United States Pfizer Investigational Site Escondido California
United States Pfizer Investigational Site Fall River Massachusetts
United States Pfizer Investigational Site Ft. Myers Florida
United States Pfizer Investigational Site Greenwood Indiana
United States Pfizer Investigational Site Hamden Connecticut
United States Pfizer Investigational Site Haverhill Massachusetts
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Lake Charles Louisiana
United States Pfizer Investigational Site Lake Jackson Texas
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Libertyville Illinois
United States Pfizer Investigational Site Lincoln Rhode Island
United States Pfizer Investigational Site Litchfield Park Arizona
United States Pfizer Investigational Site Maitland Florida
United States Pfizer Investigational Site Marietta Georgia
United States Pfizer Investigational Site Media Pennsylvania
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Middleton Wisconsin
United States Pfizer Investigational Site Murrieta California
United States Pfizer Investigational Site Naperville Illinois
United States Pfizer Investigational Site Nashua New Hampshire
United States Pfizer Investigational Site National City California
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newport Beach California
United States Pfizer Investigational Site Norristown Pennsylvania
United States Pfizer Investigational Site Norwich Connecticut
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Orange California
United States Pfizer Investigational Site Orange City Florida
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Owensboro Kentucky
United States Pfizer Investigational Site Park Ridge Illinois
United States Pfizer Investigational Site Pasadena California
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Pittsfield Massachusetts
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Prairie Village Kansas
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Redlands California
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Salem Oregon
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Sherman Oaks California
United States Pfizer Investigational Site South Miami Florida
United States Pfizer Investigational Site Temecula California
United States Pfizer Investigational Site Terre Haute Indiana
United States Pfizer Investigational Site Toledo Ohio
United States Pfizer Investigational Site Toledo Ohio
United States Pfizer Investigational Site Upland California
United States Pfizer Investigational Site Waukesha Wisconsin
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Wildomar California
United States Pfizer Investigational Site Woodstock Vermont

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The nature, incidence, and duration of adverse events monitored throughout the study by physical exam Screening, Wk 25 & Wk 52/EOT Yes
Primary 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 Yes
Primary The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events As needed Yes
Primary 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 Yes
Primary All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound Weekly Yes
Secondary 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 No
Secondary 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 No
Secondary 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 No
See also
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Completed NCT00744627 - Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults. Phase 3
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Completed NCT00525226 - Evaluating the Effects of Stress in Pregnancy N/A
Completed NCT00537615 - An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers Phase 1
Completed NCT00515242 - Therapeutic Massage for Generalized Anxiety Disorder Phase 1/Phase 2
Completed NCT00620776 - Combined Treatment for Generalized Anxiety Disorder (GAD) Phase 2

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