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

This study has been terminated.

( See termination reason in detailed description. )

First Received: March 26, 2007 Last Updated: February 21, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00452842

Purpose

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.

Condition
Cardiovascular Disease Cerebrovascular Disorders

Study Type:	Observational
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.

Resource links provided by NLM:

Drug Information available for: Atorvastatin Atorvastatin calcium Torcetrapib

U.S. FDA Resources

Further study details as provided by Pfizer:

Estimated Enrollment:	26784
Study Start Date:	October 2007

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.

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452842

Locations

United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States, 33756

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A5091075
Study First Received:	March 26, 2007
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00452842 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Torcetrapib
Antilipemic Agents
Vascular Diseases
Central Nervous System Diseases

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Brain Diseases
Cerebrovascular Disorders
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Therapeutic Uses
Cardiovascular Diseases
Atorvastatin

ClinicalTrials.gov processed this record on September 10, 2009