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A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product

Last updated on November 16, 2019

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Study Location
Pfizer Investigational Site
Boston, Massachusetts, 02114 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Siderosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- A subset of subjects enrolled in study A4321001 and who have received formulated drug
product (Lot 8716-098) will be included in the safety follow up study.

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

None

NCT00471224
Pfizer
Completed
A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product

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Descriptive Information
Brief TitleA Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product
Official TitleA Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098).
Brief SummaryThis 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).
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationA subset of subjects enrolled in study A4321001 and who have received formulated drug product.
ConditionSiderosis
InterventionOther: Observational Trial
No intervention is being used in this study.
Study Groups/CohortsPatients who have received drug.
Patients who have received drug.
Intervention: Other: Observational Trial
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 StatusCompleted
Actual Enrollment
 (submitted: May 7, 2007)
16
Original EnrollmentSame as current
Actual Study Completion DateNovember 2008
Actual Primary Completion DateNovember 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • A subset of subjects enrolled in study A4321001 and who have received formulated drug product (Lot 8716-098) will be included in the safety follow up study.

Exclusion Criteria:

None

Sex/Gender
Sexes Eligible for Study:All
Ages55 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00471224
Other Study ID NumbersA4321004
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2011

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]

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