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

NCT01829048

Last updated date
Study Location
California Clinical Trials Medical Group
Glendale, California, 91206, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

SchizophreniaStudy Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder
NCT00892021
  1. Rockville, Maryland
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaLarge Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)
NCT00418171
  1. San Bernardino, California
  2. Aiea, Hawaii
  3. Schaumburg, Illinois
  4. Grants Pass, Oregon
  5. Whitehall, West Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaAn Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia
NCT01939548
  1. Birmingham, Alabama
  2. Little Rock, Arkansas
  3. Cerritos, California
  4. Culver City, California
  5. Escondido, California
  6. Garden Grove, California
  7. Oakland, California
  8. Oceanside, California
  9. Orange, California
  10. Riverside, California
  11. San Diego, California
  12. San Diego, California
  13. Torrance, California
  14. Hartford, Connecticut
  15. Hartford, Connecticut
  16. New Haven, Connecticut
  17. Washington, District of Columbia
  18. Bradenton, Florida
  19. Brandenton, Florida
  20. Lauderhill, Florida
  21. Sanford, Florida
  22. Atlanta, Georgia
  23. Hoffman Estates, Illinois
  24. Hoffman Estates, Illinois
  25. Schaumburg, Illinois
  26. Lake Charles, Louisiana
  27. Shreveport, Louisiana
  28. Rockville, Maryland
  29. O'Fallon, Missouri
  30. St. Louis, Missouri
  31. Las Vegas, Nevada
  32. Jamaica, New York
  33. New York, New York
  34. Ward's Island, New York
  35. Dayton, Ohio
  36. Oklahoma City, Oklahoma
  37. Memphis, Tennessee
  38. Austin, Texas
  39. Austin, Texas
  40. Dallas, Texas
  41. Dallas, Texas
  42. DeSoto, Texas
  43. Salt Lake City, Utah
  44. Salt Lake City, Utah
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaAn Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia
NCT01175135
  1. Little Rock, Arkansas
  2. Anaheim, California
  3. Escondido, California
  4. Escondido, California
  5. Garden Grove, California
  6. Long Beach, California
  7. Long Beach, California
  8. Orange, California
  9. Paramount, California
  10. Paramount, California
  11. San Diego, California
  12. Santa Ana, California
  13. Torrance, California
  14. Torrance, California
  15. Washington, District of Columbia
  16. Bradenton, Florida
  17. Maitland, Florida
  18. Orlando, Florida
  19. Atlanta, Georgia
  20. Hoffman Estates, Illinois
  21. Hoffman Estates, Illinois
  22. Hoffman Estates, Illinois
  23. Lake Charles, Louisiana
  24. Lake Charles, Louisiana
  25. Rockville, Maryland
  26. Saint Louis, Missouri
  27. Willingboro, New Jersey
  28. Willingboro, New Jersey
  29. Hollis, New York
  30. Philadelphia, Pennsylvania
  31. Austin, Texas
  32. Austin, Texas
  33. Austin, Texas
  34. DeSoto, Texas
  35. Houston, Texas
  36. Houston, Texas
  37. Kirkland, Washington
  38. Kirkland, Washington
  39. Mannheim,
  40. Dnipropetrovsk,
  41. Dnipropetrovsk,
  42. Kyiv,
  43. Kyiv,
  44. Lugansk,
  45. Poltava,
  46. Stepanivka, Kherson,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: PF-02545920
    Interventions:
    • Drug: PF-02545920
    • Drug: PF-02545920
    • Drug: PF-02545920
  • Placebo Comparator: Placebo
    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 Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2013)
37
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2013)
36
Actual Study Completion Date  ICMJE October 17, 2013
Actual Primary Completion Date October 17, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (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 NCT01829048
Other Study ID Numbers  ICMJE A8241018
Has Data Monitoring Committee Yes
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