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

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Garden Grove, California, 92845 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+ 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

NCT00580125
Pfizer
Completed
Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia

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Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia
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
The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.
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-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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
164
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India,   Russian Federation,   Ukraine,   United States
 
 
NCT00580125
A7251006
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

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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