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NCT00452842 Clinical Trial

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

Cardiovascular Disease Clinical Trial

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 Torcetrapib/Atorvastatin Clinical Trials.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00452842
Other study ID # A5091075
Secondary ID
Status Terminated
Phase N/A
First received March 26, 2007
Last updated February 21, 2008
Start date October 2007

Study information
Verified date December 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 26784
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 10 Years and older
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
United States Pfizer Investigational Site Clearwater Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

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