Safety FollowUp Study Of Cardiovascular Events In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Studies

Terminated

• Conditions: Cardiovascular Disease; Cerebrovascular Disorders

• Registration Number: NCT00452842
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2007-03-26
• Study First Submitted QC: 2007-03-27
• Study First Posted: 2007-03-28
• Study Start: 2007-10
• Status Verified: 2007-12
• Last Update Submitted: 2008-02-21
• Last Update Posted: 2008-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26784

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.

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Exclusion Criteria

• There are no exclusion criteria.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Clearwater, Florida, United States