A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01829048 |
Recruitment Status :
Completed
First Posted : April 11, 2013
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science |
Condition |
Schizophrenia |
Interventions |
Drug: PF-02545920 Drug: Placebo |
Enrollment | 37 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | PF-02545920 (Cohort 1) | PF-02545920 (Cohort 2) | Placebo (Cohorts 1 and 2) | PF-02545920 (Cohort 3) | Placebo (Cohort 3) |
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Participants received PF-02545920 15 milligram (mg) orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days). | Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days). | Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days. | Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days). | Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days. |
Period Title: Overall Study | |||||
Started | 6 | 8 | 7 | 14 | 2 |
Completed | 6 | 8 | 7 | 12 | 2 |
Not Completed | 0 | 0 | 0 | 2 | 0 |
Reason Not Completed | |||||
Withdrawal by Subject | 0 | 0 | 0 | 2 | 0 |
Baseline Characteristics
Arm/Group Title | PF-02545920 (Cohort 1) | PF-02545920 (Cohort 2) | Placebo (Cohorts 1 and 2) | PF-02545920 (Cohort 3) | Placebo (Cohort 3) | Total | |
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Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 2 mg every 12 hours for 2 days, then 5 mg every 12 hours for 2 days, then 8 mg every 12 hours for 3 days, and then 15 mg every 12 hours for 3 days). | Participants received PF-02545920 15 mg orally in a titrated manner over 10 days (titration scheme: 5 mg every 12 hours for 2 days, then 10 mg every 12 hours for 2 days, and then 15 mg every 12 hours for 6 days). | Participants received placebo-matched to PF-02545920 tablets (Cohort 1 or 2) every 12 hours orally for 10 days. | Participants received PF-02545920 15 mg orally in a titrated manner over 18 days (titration scheme: 5 mg every 12 hours for 7 days, then 10 mg every 12 hours for 7 days, and then 15 mg every 12 hours for 4 days). | Participants received placebo-matched to PF-02545920 tablets (Cohort 3) every 12 hours orally for 18 days. | Total of all reporting groups | |
Overall Number of Baseline Participants | 6 | 8 | 7 | 14 | 2 | 37 | |
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Safety analysis set included all participants who received at least 1 dose of study medication.
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 6 participants | 8 participants | 7 participants | 14 participants | 2 participants | 37 participants |
less than (<) 18 years | 0 | 0 | 0 | 0 | 0 | 0 | |
18-44 years | 1 | 7 | 1 | 5 | 2 | 16 | |
45-64 | 5 | 1 | 6 | 9 | 0 | 21 | |
Greater or equal to (>=) 65 | 0 | 0 | 0 | 0 | 0 | 0 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 8 participants | 7 participants | 14 participants | 2 participants | 37 participants | |
Female |
2 33.3%
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0 0.0%
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1 14.3%
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0 0.0%
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0 0.0%
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3 8.1%
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Male |
4 66.7%
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8 100.0%
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6 85.7%
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14 100.0%
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2 100.0%
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34 91.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01829048 |
Other Study ID Numbers: |
A8241018 |
First Submitted: | March 6, 2013 |
First Posted: | April 11, 2013 |
Results First Submitted: | November 20, 2017 |
Results First Posted: | August 20, 2018 |
Last Update Posted: | August 20, 2018 |