Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
NCT ID: NCT00807937
Last Updated: 2010-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
369 participants
INTERVENTIONAL
2008-12-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
AZD7325 5mg twice daily
AZD7325
4 tablets and 1 capsule taken twice a day for 28 days
B
AZD7325 15mg twice daily
AZD7325
4 tablets and 1 capsule taken twice a day for 28 days
C
Lorazepam 2mg twice daily
Lorazepam
4 tablets and 1 capsule taken twice a day for 28 days
D
Placebo
Placebo
4 tablets and 1 capsule taken twice a day for 28 days
Interventions
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AZD7325
4 tablets and 1 capsule taken twice a day for 28 days
AZD7325
4 tablets and 1 capsule taken twice a day for 28 days
Lorazepam
4 tablets and 1 capsule taken twice a day for 28 days
Placebo
4 tablets and 1 capsule taken twice a day for 28 days
Eligibility Criteria
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Inclusion Criteria
* The patient is previously diagnosed with Generalized Anxiety Disorder.
* The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.
Exclusion Criteria
* Patient has a history of seizures or seizure disorder.
* Patient is pregnant or breast feeding.
* Patient has received electroconvulsive treatment (ECT) in the past.
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca Pharmaceuticals
Principal Investigators
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Mark A. Smith, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Mesa, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Carson, California, United States
Research Site
Escondido, California, United States
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Glendale, California, United States
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Irvine, California, United States
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Redlands, California, United States
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Riverside, California, United States
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Sherman Oaks, California, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Gainsville, Florida, United States
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Hallandale, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Orlando, Florida, United States
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St. Petersburg, 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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Hoffman Estates, Illinois, United States
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Oak Brook, Illinois, United States
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Schaumburg, Illinois, United States
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Lafayette, Indiana, United States
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Terre Haute, Indiana, United States
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Shreveport, Louisiana, United States
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Glen Burnie, Maryland, United States
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Westminster, Maryland, United States
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Braintree, Massachusetts, United States
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Piscataway, New Jersey, United States
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Cedarhurst, 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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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Willoughby, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Salem, Oregon, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Bartlett, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
Research Site
Richmond, Virginia, United States
Research Site
Seattle, Washington, United States
Countries
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Other Identifiers
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D1140C00014
Identifier Type: -
Identifier Source: org_study_id