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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00471224 |
This protocol intends to detail investigations necessary to evaluate the ocular safety of subjects enrolled in study A4321001 and who have received formulated Drug Product (Lot 8716-098).
Condition | Intervention |
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Siderosis |
Other: Observational Trial |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098). |
Enrollment: | 16 |
Study Start Date: | June 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Patients who have received drug.
Patients who have received drug.
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Other: Observational Trial
No intervention is being used in this study.
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Ages Eligible for Study: | 55 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
A subset of subjects enrolled in study A4321001 and who have received formulated drug product.
Inclusion Criteria:
Exclusion Criteria:
None
United States, Massachusetts | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02114 | |
United States, North Carolina | |
Pfizer Investigational Site | |
Charlotte, North Carolina, United States, 28210 | |
United States, Texas | |
Pfizer Investigational Site | |
Houston, Texas, United States, 77030 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4321004 |
Study First Received: | May 7, 2007 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00471224 |
Health Authority: | United States: Food and Drug Administration |
Lung Diseases, Interstitial Respiratory Tract Diseases Lung Diseases Pneumoconiosis |
Disorders of Environmental Origin Siderosis Occupational Diseases Coal worker's pneumoconiosis |