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Trial record 1 of 1 for:    NCT00471224
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A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product

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ClinicalTrials.gov Identifier: NCT00471224
Recruitment Status : Completed
First Posted : May 9, 2007
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date May 7, 2007
First Posted Date May 9, 2007
Last Update Posted Date February 17, 2011
Study Start Date June 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2007)
follow up for ocular safety and clinical features of ocular siderosis [ Time Frame: 12 months ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00471224 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 21, 2007)
  • ERG changes [ Time Frame: 12 months ]
  • Anterior segment and fundal photography [ Time Frame: 12 months ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product
Official Title A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098).
Brief Summary 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population A subset of subjects enrolled in study A4321001 and who have received formulated drug product.
Condition Siderosis
Intervention Other: Observational Trial
No intervention is being used in this study.
Study Groups/Cohorts Patients 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 Status Completed
Actual Enrollment
 (submitted: May 7, 2007)
16
Original Enrollment Same as current
Actual Study Completion Date November 2008
Actual Primary Completion Date November 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
Ages 55 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00471224
Other Study ID Numbers A4321004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2011