A Clinical Trial Comparing Torcetrapib/Atorvastatin to Ezetimibe/Simvastatin In Subjects With A Cholesterol Disorder.

December 6, 2007 updated by: Pfizer

Phase 3, Open-Label, Multi-Center, Double-Blind, Randomized, Parallel Group Study Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin, Administered Once Daily (QD) Compared to Fixed Combination Ezetimibe/Simvastatin for 6 Weeks in Subjects With Dyslipidemia.

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 combination 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

1784

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, 35235
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35209-7802
        • Pfizer Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Pfizer Investigational Site
      • Mesa, Arizona, United States, 85201
        • Pfizer Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States, 92804
        • Pfizer Investigational Site
      • Escondido, California, United States, 92025-4284
        • Pfizer Investigational Site
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Los Altos, California, United States, 94024
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90015
        • Pfizer Investigational Site
      • Palm Springs, California, United States, 92262
        • Pfizer Investigational Site
      • Paramount, California, United States, 90723
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
      • Santa Rose, California, United States, 95405
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94598
        • Pfizer Investigational Site
      • Westlake Village, California, United States, 91361
        • Pfizer Investigational Site
    • Colorado
      • Golden, Colorado, United States, 80401
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06519-1600
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Pfizer Investigational Site
    • Florida
      • Atlantis, Florida, United States, 33462
        • Pfizer Investigational Site
      • Boca Raton, Florida, United States, 33486
        • Pfizer Investigational Site
      • Daytona Beach, Florida, United States, 32114
        • Pfizer Investigational Site
      • DeFuniak Springs, Florida, United States, 32435
        • Pfizer Investigational Site
      • Destin, Florida, United States, 32541
        • Pfizer Investigational Site
      • Lakeland, Florida, United States, 33805
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33144
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33173
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
      • Pensacola, Florida, United States, 32504-8721
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30328
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Pfizer Investigational Site
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60637
        • Pfizer Investigational Site
      • Rockford, Illinois, United States, 61108
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62701
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Pfizer Investigational Site
      • Evansville, Indiana, United States, 47713
        • Pfizer Investigational Site
      • Evansville, Indiana, United States, 47712
        • Pfizer Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Pfizer Investigational Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66210
        • Pfizer Investigational Site
      • Pratt, Kansas, United States, 67124
        • Pfizer Investigational Site
      • Topeka, Kansas, United States, 66606
        • Pfizer Investigational Site
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Pfizer Investigational Site
      • Erlanger, Kentucky, United States, 41018
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40205-3374
        • Pfizer Investigational Site
    • Maryland
      • Columbia, Maryland, United States, 21044-2914
        • Pfizer Investigational Site
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02111
        • Pfizer Investigational Site
      • Milford, Massachusetts, United States, 01757
        • Pfizer Investigational Site
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Pfizer Investigational Site
      • Grand Rapids, Michigan, United States, 49525
        • Pfizer Investigational Site
      • Troy, Michigan, United States, 48098
        • Pfizer Investigational Site
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Pfizer Investigational Site
      • Edina, Minnesota, United States, 55435
        • Pfizer Investigational Site
      • St. Cloud, Minnesota, United States, 56303-1901
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Pfizer Investigational Site
      • Jefferson City, Missouri, United States, 65109
        • Pfizer Investigational Site
      • Manchester, Missouri, United States, 63021
        • Pfizer Investigational Site
      • Springfield, Missouri, United States, 65804
        • Pfizer Investigational Site
      • Springfield, Missouri, United States, 65807
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68130
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68106
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89106
        • Pfizer Investigational Site
    • New York
      • Cooperstown, New York, United States, 13326
        • Pfizer Investigational Site
      • Endwell, New York, United States, 13760
        • Pfizer Investigational Site
      • Lewiston, New York, United States, 14092
        • Pfizer Investigational Site
      • Manlius, New York, United States, 13104
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14609
        • Pfizer Investigational Site
      • Syracuse, New York, United States, 13202
        • Pfizer Investigational Site
      • West Seneca, New York, United States, 14224
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28209-3734
        • Pfizer Investigational Site
      • Huntersville, North Carolina, United States, 28078
        • Pfizer Investigational Site
      • Monroe, North Carolina, United States, 28112
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Pfizer Investigational Site
      • Wilmington, North Carolina, United States, 28412
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103-3315
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
      • Fairview Park, Ohio, United States, 44126
        • Pfizer Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Pfizer Investigational Site
      • Bensalem, Pennsylvania, United States, 19020
        • Pfizer Investigational Site
      • Doylestown, Pennsylvania, United States, 18901
        • Pfizer Investigational Site
      • Harleysville, Pennsylvania, United States, 19438
        • Pfizer Investigational Site
      • Lancaster, Pennsylvania, United States, 17603
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • Pfizer Investigational Site
      • Sayre, Pennsylvania, United States, 18840
        • Pfizer Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Pfizer Investigational Site
      • Providence, Rhode Island, United States, 02906
        • Pfizer Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Pfizer Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Pfizer Investigational Site
      • Chattanooga, Tennessee, United States, 37404
        • Pfizer Investigational Site
      • Germantown, Tennessee, United States, 38138
        • Pfizer Investigational Site
      • Johnson City, Tennessee, United States, 37601
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38104
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38128
        • Pfizer Investigational Site
      • Selmer, Tennessee, United States, 38375
        • Pfizer Investigational Site
    • Texas
      • Arlington, Texas, United States, 76017
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77054
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78238
        • Pfizer Investigational Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84102
        • Pfizer Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Pfizer Investigational Site
      • Norfolk, Virginia, United States, 23502
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, United States, 98055
        • Pfizer Investigational Site
      • Spokane, Washington, United States, 99216
        • 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:

  • Specific LDL-C levels based on CHD risk after a six-week washout period.

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 requiring systemic steroids
  • Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study.

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: Double

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

Study Completion (Actual)

January 1, 2007

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)

December 10, 2007

Last Update Submitted That Met QC Criteria

December 6, 2007

Last Verified

December 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5091035

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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