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A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia

Last updated on August 21, 2018

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Study Location
California Clinical Trials Medical Group
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
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Psychiatrically stable subjects with schizophrenia.

- Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.

- Subjects must be on a stable medication treatment regimen greater than or equal to 2
months, including concomitant psychotropic medications.

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

- History of seizures or of a condition with risk of seizures.

- Subjects who have had electroconvulsive therapy within the 6 months prior to
randomization.

- Pregnant or nursing females, and females of child bearing potential.

NCT01829048
Pfizer
Completed
A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia

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A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia
A Randomized, Double-Blind, Placebo Controlled, Sponsor Open, Phase 1b Study To Examine The Adjunctive Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia
To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/- other adjunctive medication.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Schizophrenia
  • Drug: PF-02545920
    15 mg (2 mg X 2d, 5 mg X 2d, 8 mg X 3 d, then 15 mg) Q12h
    Other Name: Cohort 1
  • Drug: PF-02545920
    15 mg (5 mg X 2d, 10 mg X 2d, then 15 mg) Q12h
    Other Name: Cohort 2
  • Drug: PF-02545920
    15 mg (5 mg BID for 7 days 10 mg BID for 7 days, then 15 mg BID for 4 days) Q12h
    Other Name: Cohort 3
  • Drug: Placebo
    Placebo Q12h
  • Experimental: PF-02545920
    Interventions:
    • Drug: PF-02545920
    • Drug: PF-02545920
    • Drug: PF-02545920
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Psychiatrically stable subjects with schizophrenia.
  • Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
  • Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.

Exclusion Criteria:

  • History of seizures or of a condition with risk of seizures.
  • Subjects who have had electroconvulsive therapy within the 6 months prior to randomization.
  • Pregnant or nursing females, and females of child bearing potential.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01829048
A8241018
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

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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