Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo

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NCT00570063

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Study Location
California Clinical Trials Medical Group, Inc.
Glendale, California, 91206, United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Have a current diagnosis of schizophrenia.

2. Increase in symptoms over the past 2-4 weeks.

3. Willing to remain inpatients for the duration of the trial.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Evidence or history of clinically significant medical problems.


2. Females of childbearing potential.


3. A primary psychiatric diagnosis other than schizophrenia.


4. A diagnosis of substance abuse or dependence in the last 6 months.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo
Official Title  ICMJE A Phase 2, Multicenter, Double-blind, Randomized, Fixed Dose, Parallel Group, 3-week Inpatient Treatment Study To Evaluate The Safety, Efficacy And Pharmacokinetics Of Pf-02545920 Compared With Placebo In The Treatment Of Acute Exacerbation Of Schizophrenia
Brief Summary To assess the efficacy and safety of an investigational compound PF-02545920 for the treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing symptoms associated with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: PF-02545920
    Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days
  • Drug: Placebo
    Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days.
Study Arms  ICMJE
  • Placebo Comparator: 1
    PF-02545920 15 mg tablets taken twice a day by mouth for 21 days
    Intervention: Drug: PF-02545920
  • Placebo Comparator: 2
    Matching placebo tablets taken twice a day by mouth for 21 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 9, 2008)		35
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2007)		54
Actual Study Completion Date  ICMJE February 18, 2008
Actual Primary Completion Date February 18, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Have a current diagnosis of schizophrenia.
  2. Increase in symptoms over the past 2-4 weeks.
  3. Willing to remain inpatients for the duration of the trial.

Exclusion Criteria:

  1. Evidence or history of clinically significant medical problems.
  2. Females of childbearing potential.
  3. A primary psychiatric diagnosis other than schizophrenia.
  4. A diagnosis of substance abuse or dependence in the last 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00570063
Other Study ID Numbers  ICMJE A8241006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP