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A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

NCT ID: NCT00542685

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

551 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-12-31

Brief Summary

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This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.

Detailed Description

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Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PD 0332334 300 mg BID

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.

Placebo BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules, oral, placebo BID, 8 weeks with 2 week taper.

PD 0332334 225 mg BID

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.

PD 0332334 175 mg BID

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.

Interventions

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PD 0332334

Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.

Intervention Type DRUG

Placebo

Capsules, oral, placebo BID, 8 weeks with 2 week taper.

Intervention Type DRUG

PD 0332334

Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.

Intervention Type DRUG

PD 0332334

Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.

Intervention Type DRUG

Other Intervention Names

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imagabalin

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of GAD (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
* Subjects must have a HAM-A total score ≥20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of \>9 and a Raskin Depression Scale score \<7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.

Exclusion Criteria

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
* Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder, Obsessive compulsive disorder, Panic disorder; Agoraphobia, Posttraumatic stress disorder, Anorexia, Bulimia, Caffeine-induced anxiety disorder, Alcohol or substance abuse or dependence unless in full remission for at least 6 months, Social anxiety disorder.
* Any of the following past or current DSM IV Axis I diagnoses: Schizophrenia, Psychotic disorder, Delirium, dementia, amnestic, and other clinically significant cognitive disorders, Bipolar or schizoaffective disorder, Cyclothymic disorder, Dissociative disorders.
* Antisocial or borderline personality disorder.
* Serious suicidal risk per the clinical investigator's judgment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Beverly Hills, California, United States

Site Status

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Encino, California, United States

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National City, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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Sherman Oaks, California, United States

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Farmington, Connecticut, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Libertyville, Illinois, United States

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Schaumburg, Illinois, United States

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Lafayette, Indiana, United States

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Owensboro, Kentucky, United States

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Lake Charles, Louisiana, United States

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Glen Burnie, Maryland, United States

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Rockville, Maryland, United States

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Belmont, Massachusetts, United States

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Fall River, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Nashua, New Hampshire, United States

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Cherry Hill, New Jersey, United States

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Piscataway, New Jersey, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Charleston, South Carolina, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Middleton, Wisconsin, United States

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Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5361017&StudyName=A%2010-Week%20Study%20Evaluating%20the%20Efficacy%20And%20Safety%20of%20PD%200332334%20for%20the%20Treatment%20of%20Generalized%20Anxiety%20Disorder

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

Other Identifiers

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A5361017

Identifier Type: -

Identifier Source: org_study_id