An Observational Safety Follow Up Trial Of The Occurrence Of Major Cardiovascular Events And All Cause Mortality In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Clinical Trials.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- Pfizer
- Enrollment
- 26784
- Locations
- 1
- Status
- Terminated
- Last Updated
- 18 years ago
Overview
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 torcetrapib/atorvastatin 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have signed informed consent prior to the initiation of any study-specific activities.
- •Have participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials and were treated with randomized study medication.
Exclusion Criteria
- •There are no exclusion criteria.
Outcomes
Primary Outcomes
Not specified