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See termination reason in detailed description.
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This study is examining the efficacy of PF-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with schizophrenia.
The study was terminated on August 25, 2010 because the study's scientific validity could no longer be supported. The decision to terminate the trial was not based on any safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-03463275 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03463275 | Drug | 30 mg Controlled Release tablet BID for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score | 12 weeks | |
| Vital Signs (Blood pressure, heart rate) | 15 weeks | |
| ECG | 15 weeks | |
| Safety laboratory assessments | 15 weeks | |
| Adverse events | 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Quality of Life Scale (QLS) | 12 weeks | |
| Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores | 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Cerritos | California | 90703 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo |
| Drug |
Placebo tablet BID |
|
| Change from baseline in PANSS Total |
| 12 weeks |
| Change from baseline in PANSS Positive Subscale | 12 weeks |
| Change from baseline in PANSS General Subscale | 12 weeks |
| Change from baseline in Clinical Global Impression Severity (CGI-S) | 12 weeks |
| Clinical Global Impression Improvement (CGI-I) Total Score | 12 weeks |
| Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified | 12 weeks |
| Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale | 12 weeks |
| Change from baseline in Global Assessment of Functioning | 12 weeks |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | 15 weeks |
| Pharmacokinetic assays | 12 weeks |
| Chula Vista |
| California |
| 91910 |
| United States |
| Pfizer Investigational Site | Escondido | California | 92025 | United States |
| Pfizer Investigational Site | Garden Grove | California | 92845 | United States |
| Pfizer Investigational Site | Glendale | California | 91436 | United States |
| Pfizer Investigational Site | Long Beach | California | 90805 | United States |
| Pfizer Investigational Site | Long Beach | California | 90808 | United States |
| Pfizer Investigational Site | National City | California | 91950 | United States |
| Pfizer Investigational Site | Paramount | California | 90723 | United States |
| Pfizer Investigational Site | Torrance | California | 90502 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20016 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20036 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30308 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30328 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30342 | United States |
| Pfizer Investigational Site | Decatur | Georgia | 30333 | United States |
| Pfizer Investigational Site | Park Ridge | Illinois | 60068 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67207 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67211 | United States |
| Pfizer Investigational Site | Flowood | Mississippi | 39232 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89102 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89128 | United States |
| Pfizer Investigational Site | Runnemede | New Jersey | 08078 | United States |
| Pfizer Investigational Site | Toms River | New Jersey | 08755 | United States |
| Pfizer Investigational Site | Willingboro | New Jersey | 08046 | United States |
| Pfizer Investigational Site | Fresh Meadows | New York | 11366 | United States |
| Pfizer Investigational Site | Holliswood | New York | 11423 | United States |
| Pfizer Investigational Site | Staten Island | New York | 10304 | United States |
| Pfizer Investigational Site | Staten Island | New York | 10305 | United States |
| Pfizer Investigational Site | Edmond | Oklahoma | 73034 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73116 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19139 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38119 | United States |
| Pfizer Investigational Site | Austin | Texas | 78731 | United States |
| Pfizer Investigational Site | Austin | Texas | 78754 | United States |
| Pfizer Investigational Site | Bellaire | Texas | 77401 | United States |
| Pfizer Investigational Site | Houston | Texas | 77008 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C549926 | 1-methyl-1H-imidazole-4-carboxylic acid (3-chloro-4-fluoro-benzyl)-(3-methyl-3-aza-bicyclo(3.1.0) hex-6-ylmethyl)amide |
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