Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-27 @ 9:23 AM
Study NCT ID:
NCT00823966
Status:
COMPLETED
Last Update Posted:
2010-07-05
First Post:
2009-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed Description:
All the patients whom an investigator prescribes the first Rescriptor® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: