Phase IIA Study in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00686998
First received: May 28, 2008
Last updated: March 20, 2013
Last verified: March 2013
Results First Received: April 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: AZD2624
Drug: Olanzapine
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
A total of 2 centers in the US were initiated and enrolled patients. 159 patients enrolled, of which 106 randomized

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened up to 21 days, and admitted to the Clinical Research Unit (CRU) for a maximum of 2 days until eligibility was determined. Once eligibility was determined, patients currently on medication entered a 7 days washout period, patients not currently on medication had a 3 day washout, prior to randomization to study medication.

Reporting Groups
  Description
AZD2624 AZD2624 40 mg
Placebo Matching Placebo
Olanzapine Olanzapine 15 mg

Participant Flow:   Overall Study
    AZD2624     Placebo     Olanzapine  
STARTED     43 [1]   41 [1]   22 [1]
Randomized     43     41     22  
Received Treatment     43     41     22  
Eligible for Efficacy Analysis     42     39     21  
Completed Scheduled Treatment     30     33     18  
COMPLETED     30     33     18  
NOT COMPLETED     13     8     4  
Adverse Event                 3                 2                 1  
Withdrawal by Subject                 2                 1                 2  
Lack of Efficacy                 7                 5                 0  
Not specified                 0                 0                 1  
Safety Reasons                 1                 0                 0  
[1] Randomized & received study medication



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD2624 AZD2624 40 mg
Placebo Matching Placebo
Olanzapine Olanzapine 15 mg
Total Total of all reporting groups

Baseline Measures
    AZD2624     Placebo     Olanzapine     Total  
Number of Participants  
[units: participants]
  43     41     22     106  
Age  
[units: Year]
Mean ± Standard Deviation
  40.1  ± 12     40.2  ± 11.6     35.3  ± 8.7     39.2  ± 11.3  
Gender  
[units: Participants]
       
Female     3     2     0     5  
Male     40     39     22     101  



  Outcome Measures

1.  Primary:   Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline   [ Time Frame: Baseline, Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: AstraZeneca
ClinicalTrials.gov Identifier: NCT00686998     History of Changes
Other Study ID Numbers: D0970C00004
Study First Received: May 28, 2008
Results First Received: April 28, 2010
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board