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Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
George, , South Africa
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Schizo-Affective Disorder
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

- Subjects with DSM-IV diagnosis of schizophrenia or schizo-affective disorder for whom
antipsychotic monotherapy is indicated.

- Subjects must be free from an acute exacerbation of psychosis for at least 3 months
prior to screening.

- Current Clinical Global Impression (CGI) of Severity of Illness score ≤3.

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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, neurological, or allergic
disease (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing).

- Evidence or history of a primary DSM-IV axis I diagnosis other than schizophrenia or
schizoaffective disorder.

- Any condition possibly affecting drug absorption (e.g., gastrectomy).

NCT00463372
Pfizer
Completed
Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia

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Similar Trials

Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia
A Phase I, Investigator And Subject-Blind (Sponsor Unblinded), Placebo-Controlled Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-02545920 After Multiple Oral Dose Administration In Subjects With Stable Schizophrenia
To evaluate the safety and tolerability of multiple doses of PF-02545920 subjects with schizophrenia or schizo-affective disorder who are currently clinically stable and to evaluate the serum and urine pharmacokinetics of PF-02545920 and the N-desmethyl metabolite, PF-01001252, after multiple doses of PF-02545920 administered orally.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Schizophrenia
  • Schizo-Affective Disorder
Drug: PF-02545920
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2007
Not Provided

Inclusion Criteria:

  • Subjects with DSM-IV diagnosis of schizophrenia or schizo-affective disorder for whom antipsychotic monotherapy is indicated.
  • Subjects must be free from an acute exacerbation of psychosis for at least 3 months prior to screening.
  • Current Clinical Global Impression (CGI) of Severity of Illness score ??3.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Evidence or history of a primary DSM-IV axis I diagnosis other than schizophrenia or schizoaffective disorder.
  • Any condition possibly affecting drug absorption (e.g., gastrectomy).
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
 
NCT00463372
A8241002
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2007

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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