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Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00807937
First received: December 12, 2008
Last updated: September 16, 2010
Last verified: September 2010
History of Changes
Results First Received: July 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anxiety Disorders
Interventions: Drug: AZD7325
Drug: Lorazepam
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
International multi-center study, 43 sites recruited between Dec 2008 and May 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility and wash-out of restriced medications

Reporting Groups
  Description
AZD7325 5 mg AZD7325 5 mg twice daily (BID)
AZD7325 15 mg AZD7325 15 mg twice daily (BID)
Lorazepam Lorazepam 2 mg twice daily (BID)
Placebo Placebo

Participant Flow:   Overall Study
    AZD7325 5 mg     AZD7325 15 mg     Lorazepam     Placebo  
STARTED     93     92     92     92  
COMPLETED     66     67     78     77  
NOT COMPLETED     27     25     14     15  
Adverse Event                 12                 12                 5                 4  
Protocol Violation                 4                 5                 3                 3  
Withdrawal by Subject                 5                 4                 1                 4  
Lost to Follow-up                 4                 0                 2                 1  
Lack of Efficacy                 0                 0                 1                 2  
Intake of prohibited medicine                 0                 0                 2                 0  
All other reasons (not provided)                 2                 4                 0                 1  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score   [ Time Frame: Baseline to week 4 ]
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2.  Secondary:   Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score   [ Time Frame: Baseline to week 4 ]
  Show Outcome Measure 2

3.  Secondary:   Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score   [ Time Frame: Baseline to week 4 ]
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4.  Secondary:   Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score   [ Time Frame: Baseline to week 4 ]
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5.  Secondary:   Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score   [ Time Frame: Baseline to week 4 ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: Mark A. Smith, MD PhD, Medical Science Director, Emerging Psychiatry, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00807937     History of Changes
Other Study ID Numbers: D1140C00014
Study First Received: December 12, 2008
Results First Received: July 29, 2010
Last Updated: September 16, 2010
Health Authority: United States: Food and Drug Administration