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

Primary Purpose

Cardiovascular Disease, Cerebrovascular Disorders

Status
Terminated
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Disease

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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 exclusion criteria.

Sites / Locations

  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 26, 2007
Last Updated
February 21, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00452842
Brief Title
Safety FollowUp Study Of Cardiovascular Events In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Studies
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.
Study Type
Observational

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Cerebrovascular Disorders

7. Study Design

Enrollment
26784 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5091075&StudyName=Safety%20FollowUp%20Study%20Of%20Cardiovascular%20Events%20In%20Subjects%20Who%20Participated%20In%20Selected%20Torcetrapib/Atorvastatin%20Studies
Description
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Learn more about this trial

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

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