Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia

NCT00580125

Last updated date
Study Location
Pfizer Investigational Site
Garden Grove, California, 92845, United States
Contact
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 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Key inclusion criteria include:

- Have a current diagnosis of schizophrenia.

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

- 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


- Subjects with a current DSM-IV axis I diagnosis other than schizophrenia


- Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence


- Subjects with a history of treatment resistant schizophrenia


- Females of childbearing potential

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Advanced Information
Descriptive Information
Brief Title  ICMJE Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia
Official Title  ICMJE A Phase 2, Multicenter, Double-Blind, Randomized, Fixed Dose, Parallel Group, 3-Week Inpatient Treatment Study To Evaluate The Dose-Response Relationship, Safety, Efficacy, And Pharmacokinetics Of PF-00217830 Compared With Placebo, Using Aripiprazole As A Positive Control, In The Treatment Of Acute Exacerbation Of Schizophrenia
Brief Summary The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.
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-00217830
    PF-00217830 5 mg, oral capsule, once daily for 21 days
  • Other: Placebo
    Placebo, oral capsule, once daily for 21 days
  • Drug: Aripiprazole
    Aripiprazole 15 mg, oral capsule, once daily for 21 days
    Other Name: Abilify
  • Drug: PF-00217830
    PF-00217830 15 mg, oral capsule, once daily for 21 days
  • Drug: PF-00217830
    PF-00217830 2 mg, oral capsule, once daily for 21 days
Study Arms  ICMJE
  • Experimental: A2
    Intervention: Drug: PF-00217830
  • Placebo Comparator: A5
    Intervention: Other: Placebo
  • Active Comparator: A4
    Intervention: Drug: Aripiprazole
  • Experimental: A3
    Intervention: Drug: PF-00217830
  • Experimental: A1
    Intervention: Drug: PF-00217830
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2008)
164
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2007)
160
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Key inclusion criteria include:

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

Exclusion Criteria:

  • Subjects with a current DSM-IV axis I diagnosis other than schizophrenia
  • Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence
  • Subjects with a history of treatment resistant schizophrenia
  • Females of childbearing potential
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 India,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00580125
Other Study ID Numbers  ICMJE A7251006
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 January 2011

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