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

Last updated on May 10, 2018

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

NCT00570063
Pfizer
Terminated
Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo

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Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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.
  • Placebo Comparator: 2
    Matching placebo tablets taken twice a day by mouth for 21 days
    Intervention: Drug: Placebo
  • Placebo Comparator: 1
    PF-02545920 15 mg tablets taken twice a day by mouth for 21 days
    Intervention: Drug: PF-02545920
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
February 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00570063
A8241006
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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