A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol

February 15, 2012 updated by: Pfizer

A Phase 3, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally Once Daily for 6 Months, Compared to Atorvastatin Alone or Placebo in Subjects With Mixed Dyslipidemia (Fredrickson Types IIa and IIb).

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

A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo.

Study Overview

Detailed Description

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

Study Type

Interventional

Enrollment

3800

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

      • Bruxelles, Belgium
        • Pfizer Investigational Site
      • Dottignies, Belgium
        • Pfizer Investigational Site
      • Ham, Belgium
        • Pfizer Investigational Site
      • Hasselt, Belgium
        • Pfizer Investigational Site
      • Hoeilaart, Belgium
        • Pfizer Investigational Site
      • La Louviere, Belgium
        • Pfizer Investigational Site
      • Leuven, Belgium
        • Pfizer Investigational Site
      • Wilsele, Belgium
        • Pfizer Investigational Site
      • Beckum, Germany
        • Pfizer Investigational Site
      • Berlin, Germany
        • Pfizer Investigational Site
      • Bochum, Germany
        • Pfizer Investigational Site
      • Erlangen, Germany
        • Pfizer Investigational Site
      • Essen, Germany
        • Pfizer Investigational Site
      • Feldafing, Germany
        • Pfizer Investigational Site
      • Hamburg, Germany
        • Pfizer Investigational Site
      • Heidelberg, Germany
        • Pfizer Investigational Site
      • Homburg/Saar, Germany
        • Pfizer Investigational Site
      • Karlsruhe, Germany
        • Pfizer Investigational Site
      • Kuenzing, Germany
        • Pfizer Investigational Site
      • Nuernberg, Germany
        • Pfizer Investigational Site
      • Offenbach, Germany
        • Pfizer Investigational Site
      • Rodgau, Germany
        • Pfizer Investigational Site
      • Schwerin, Germany
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of
        • Pfizer Investigational Site
      • Suwon, Korea, Republic of
        • Pfizer Investigational Site
      • Puebla, Mexico
        • Pfizer Investigational Site
    • D.f.
      • Mexico, D.f., Mexico
        • Pfizer Investigational Site
      • Tlalpan, D.f., Mexico
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Pfizer Investigational Site
      • Bekkestua, Norway
        • Pfizer Investigational Site
      • Elverum, Norway
        • Pfizer Investigational Site
      • Honefoss, Norway
        • Pfizer Investigational Site
      • Jessheim, Norway
        • Pfizer Investigational Site
      • Kongsberg, Norway
        • Pfizer Investigational Site
      • Lena, Norway
        • Pfizer Investigational Site
      • Lierskogen, Norway
        • Pfizer Investigational Site
      • Molde, Norway
        • Pfizer Investigational Site
      • Moss, Norway
        • Pfizer Investigational Site
      • Oslo, Norway
        • Pfizer Investigational Site
      • Roverud, Norway
        • Pfizer Investigational Site
      • Skedsmokorset, Norway
        • Pfizer Investigational Site
      • Tromso, Norway
        • Pfizer Investigational Site
      • Goteborg, Sweden
        • Pfizer Investigational Site
      • Jarfalla, Sweden
        • Pfizer Investigational Site
      • Linkoping, Sweden
        • Pfizer Investigational Site
      • Orebro, Sweden
        • Pfizer Investigational Site
      • Strangnas, Sweden
        • Pfizer Investigational Site
      • Umea, Sweden
        • Pfizer Investigational Site
    • Cornwall
      • Penzance, Cornwall, United Kingdom
        • Pfizer Investigational Site
    • Devon
      • Woolwell, Plymouth, Devon, United Kingdom
        • Pfizer Investigational Site
    • Harrow
      • Middlesex, Harrow, United Kingdom
        • Pfizer Investigational Site
    • Hertfordshire
      • Garston, Hertfordshire, United Kingdom
        • Pfizer Investigational Site
    • Lancashire
      • Blackpool, Lancashire, United Kingdom
        • Pfizer Investigational Site
    • Lancs. Fy3 7dq
      • Blackpool, Lancs. Fy3 7dq, United Kingdom
        • Pfizer Investigational Site
    • Surrey
      • Addlestone, Surrey, United Kingdom
        • Pfizer Investigational Site
      • East Horsley, Leatherhead, Surrey, United Kingdom
        • Pfizer Investigational Site
    • Wiltshire
      • Warminster, Wiltshire, United Kingdom
        • Pfizer Investigational Site
    • Alabama
      • Mobile, Alabama, United States
        • Pfizer Investigational Site
    • Arizona
      • Mesa, Arizona, United States
        • Pfizer Investigational Site
      • Oro Valley, Arizona, United States
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States
        • Pfizer Investigational Site
      • Sun City, Arizona, United States
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States
        • Pfizer Investigational Site
      • Carmichael, California, United States
        • Pfizer Investigational Site
      • Concord, California, United States
        • Pfizer Investigational Site
      • Greenbrae, California, United States
        • Pfizer Investigational Site
      • Los Angeles, California, United States
        • Pfizer Investigational Site
      • Mission Viejo, California, United States
        • Pfizer Investigational Site
      • Sacramento, California, United States
        • Pfizer Investigational Site
      • Santa Ana, California, United States
        • Pfizer Investigational Site
      • Stockton, California, United States
        • Pfizer Investigational Site
      • Thouasand Oaks, California, United States
        • Pfizer Investigational Site
      • Tustin, California, United States
        • Pfizer Investigational Site
      • Upland, California, United States
        • Pfizer Investigational Site
      • Walnut Creek, California, United States
        • Pfizer Investigational Site
      • Westlake Village, California, United States
        • Pfizer Investigational Site
    • Colorado
      • Boulder, Colorado, United States
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, United States
        • Pfizer Investigational Site
    • Florida
      • Coral Gables, Florida, United States
        • Pfizer Investigational Site
      • Ft. Pierce, Florida, United States
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States
        • Pfizer Investigational Site
      • Jupiter, Florida, United States
        • Pfizer Investigational Site
      • Lake Worth, Florida, United States
        • Pfizer Investigational Site
      • Melbourne, Florida, United States
        • Pfizer Investigational Site
      • Palm Bay, Florida, United States
        • Pfizer Investigational Site
      • Sebastian, Florida, United States
        • Pfizer Investigational Site
      • Stuart, Florida, United States
        • Pfizer Investigational Site
      • Vero Beach, Florida, United States
        • Pfizer Investigational Site
      • Wellington, Florida, United States
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • Pfizer Investigational Site
      • Creve Coevr, Illinois, United States
        • Pfizer Investigational Site
      • Peoria, Illinois, United States
        • Pfizer Investigational Site
      • Rockford, Illinois, United States
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, United States
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States
        • Pfizer Investigational Site
      • Wichita, Kansas, United States
        • Pfizer Investigational Site
    • Kentucky
      • Erlanger, Kentucky, United States
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States
        • Pfizer Investigational Site
    • Louisiana
      • Covington, Louisiana, United States
        • Pfizer Investigational Site
      • Slidell, Louisiana, United States
        • Pfizer Investigational Site
    • Maine
      • Scarborough, Maine, 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
    • Mississippi
      • Jackson, Mississippi, United States
        • Pfizer Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States
        • Pfizer Investigational Site
    • Montana
      • Billings, Montana, United States
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Pfizer Investigational Site
    • New York
      • Endwell, New York, United States
        • Pfizer Investigational Site
      • Lake Success, New York, United States
        • Pfizer Investigational Site
      • Rochester, New York, United States
        • Pfizer Investigational Site
      • Williamsville, New York, United States
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Pfizer Investigational Site
      • Concord, North Carolina, United States
        • Pfizer Investigational Site
      • Fayetteville, North Carolina, United States
        • Pfizer Investigational Site
      • Monroe, North Carolina, United States
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Pfizer Investigational Site
      • Elyria, Ohio, United States
        • Pfizer Investigational Site
      • Olmsted Township, Ohio, United States
        • Pfizer Investigational Site
      • Westlake, Ohio, United States
        • Pfizer Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Pfizer Investigational Site
    • Oregon
      • Beaverton, Oregon, United States
        • Pfizer Investigational Site
      • Hillsboro, Oregon, United States
        • Pfizer Investigational Site
      • Portland, Oregon, United States
        • Pfizer Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States
        • Pfizer Investigational Site
    • South Carolina
      • Greer, South Carolina, United States
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, United States
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States
        • Pfizer Investigational Site
      • Beaumont, Texas, United States
        • Pfizer Investigational Site
      • Bryan, Texas, United States
        • Pfizer Investigational Site
      • Dallas, Texas, United States
        • Pfizer Investigational Site
      • Houston, Texas, United States
        • Pfizer Investigational Site
      • San Antonio, Texas, United States
        • Pfizer Investigational Site
      • The Colony, Texas, United States
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • Pfizer Investigational Site
    • Virginia
      • Newport News, Virginia, United States
        • Pfizer Investigational Site
      • Norfolk, Virginia, United States
        • Pfizer Investigational Site
      • Richmond, Virginia, United States
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, United States
        • Pfizer Investigational Site
      • Yakima, Washington, United States
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Pfizer Investigational Site
      • Oregon, Wisconsin, 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:

  • subjects with elevated cholesterol

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Intolerance to statin therapy resulting in withdrawal
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
  • 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
LDL and HDL levels

Secondary Outcome Measures

Outcome Measure
other lipid parameters

Collaborators and Investigators

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

Sponsor

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

July 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 30, 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

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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