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

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.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00452842

Enrollment

26784

Registered

2007-03-28

Start date

2007-10-31

Completion date

Unknown

Last updated

2008-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Cerebrovascular Disorders

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results