Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452842
Status:
TERMINATED
Last Update Posted:
2008-02-22
First Post:
2007-03-26
Brief Title:
Safety FollowUp Study Of Cardiovascular Events In Subjects Who Participated In Selected TorcetrapibAtorvastatin Studies
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
An Observational Safety Follow Up Trial Of The Occurrence Of Major Cardiovascular Events And All Cause Mortality In Subjects Who Participated In Selected TorcetrapibAtorvastatin Clinical Trials
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An observational safety follow up trial will be conducted to monitor the occurrence of cardiovascular events and all cause mortality in subjects who participated in selected torcetrapibatorvastatin Phase 1 2 and 3 clinical trials No hypotheses will be tested
Detailed Description:
Study A5091075 an observational study in subjects who had previously been treated with torcetrapib was terminated on 20 Dec 2007 The study was terminated following reviews of final safety information from prior torcetrapib studies and the low participation rates observed during the recruitment period for study A5091075 On the basis of this new information the Sponsor determined that it was unlikely that this study would result in new and scientifically valid information
Study Oversight
Has Oversight DMC:
None
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?:
None