A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

February 15, 2012 updated by: Pfizer

A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091031)

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

For additional information please call: 1-800-718-1021

Study Type

Interventional

Enrollment

640

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Pfizer Investigational Site
    • Arizona
      • Mesa, Arizona, United States
        • Pfizer Investigational Site
    • California
      • Alhambra, California, United States
        • Pfizer Investigational Site
      • Inglewood, California, United States
        • Pfizer Investigational Site
      • Los Angeles, California, United States
        • Pfizer Investigational Site
      • Santa Ana, California, United States
        • Pfizer Investigational Site
    • Delaware
      • Wilmington, Delaware, United States
        • Pfizer Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States
        • Pfizer Investigational Site
      • Hollywood, Florida, United States
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States
        • Pfizer Investigational Site
      • Merritt Island, Florida, United States
        • Pfizer Investigational Site
      • Pensacola, Florida, United States
        • Pfizer Investigational Site
      • Vero Beach, Florida, United States
        • Pfizer Investigational Site
      • Winter Park, Florida, United States
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • Pfizer Investigational Site
      • Conyers, Georgia, United States
        • Pfizer Investigational Site
      • Woodstock, Georgia, United States
        • Pfizer Investigational Site
    • Illinois
      • Hinsdale, Illinois, United States
        • Pfizer Investigational Site
      • La Grange, Illinois, United States
        • Pfizer Investigational Site
      • Park Ridge, Illinois, United States
        • Pfizer Investigational Site
      • Springfield, Illinois, United States
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • Pfizer Investigational Site
      • Bethesda, Maryland, United States
        • Pfizer Investigational Site
      • Elkton, Maryland, United States
        • Pfizer Investigational Site
    • Michigan
      • Flint, Michigan, United States
        • Pfizer Investigational Site
    • Missouri
      • Springfield, Missouri, United States
        • Pfizer Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States
        • Pfizer Investigational Site
      • Seaford, New York, United States
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Pfizer Investigational Site
      • Mansfield, Ohio, United States
        • Pfizer Investigational Site
    • Oregon
      • Hillsboro, Oregon, United States
        • Pfizer Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States
        • Pfizer Investigational Site
      • Flourtown, Pennsylvania, United States
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States
        • Pfizer Investigational Site
      • Yardley, Pennsylvania, United States
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States
        • Pfizer Investigational Site
    • Tennessee
      • Collierville, Tennessee, United States
        • Pfizer Investigational Site
      • Kingsport, Tennessee, United States
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States
        • Pfizer Investigational Site
    • Texas
      • North Richland Hills, Texas, United States
        • Pfizer Investigational Site
      • Spring, Texas, United States
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • Pfizer Investigational Site
      • West Jordan, Utah, United States
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States
        • Pfizer Investigational Site
    • Washington
      • Bellevue, Washington, United States
        • Pfizer Investigational Site
      • Puyallup, Washington, United States
        • Pfizer Investigational Site
      • Tacoma, Washington, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
  • Subjects with significant liver or kidney disease or significant heart failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Changes in other lipid parameters and other biomarkers.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

December 19, 2005

First Submitted That Met QC Criteria

December 19, 2005

First Posted (Estimate)

December 20, 2005

Study Record Updates

Last Update Posted (Estimate)

February 17, 2012

Last Update Submitted That Met QC Criteria

February 15, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5091031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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