Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.

November 15, 2007 updated by: Pfizer

A Phase 3, Double-Blind, Randomized, Multisite Trial Of The Efficacy, Safety, And Tolerability Of The Fixed Combination Torcetrapib/Atorvastatin Administered Orally, Once Daily For 12 Months, Compared To Atorvastatin Alone, Titrated Based On NCEP ATP-III LDL-C Goals In Subjects With Fredrickson Types IIa And IIb Dyslipidemias

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

To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Interventional

Enrollment

900

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

    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Pfizer Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6G 2M3
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1H 8K7
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Pfizer Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 1L2
        • Pfizer Investigational Site
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Pfizer Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Pfizer Investigational Site
      • St. Georges de Beauce, Quebec, Canada, G5Y 4W1
        • Pfizer Investigational Site
    • Alabama
      • Huntsville, Alabama, United States, 35802
        • Pfizer Investigational Site
      • Union Grove, Alabama, United States, 35175
        • Pfizer Investigational Site
    • California
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90057
        • Pfizer Investigational Site
      • Orange, California, United States, 92868
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80262
        • Pfizer Investigational Site
      • Golden, Colorado, United States, 80401
        • Pfizer Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Pfizer Investigational Site
      • Fairfield, Connecticut, United States, 06824
        • Pfizer Investigational Site
      • Trumbull, Connecticut, United States, 06611
        • Pfizer Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Pfizer Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Pfizer Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32610
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32605
        • Pfizer Investigational Site
      • Gainsville, Florida, United States, 32610
        • Pfizer Investigational Site
      • Sebastian, Florida, United States, 32958
        • Pfizer Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Pfizer Investigational Site
    • Illinois
      • Rockford, Illinois, United States, 61108
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62704
        • Pfizer Investigational Site
    • Kansas
      • Olathe, Kansas, United States, 66061
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66210
        • Pfizer Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Pfizer Investigational Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Pfizer Investigational Site
      • Troy, Michigan, United States, 48098
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87106
        • Pfizer Investigational Site
    • New York
      • Orchard Park, New York, United States, 14127
        • Pfizer Investigational Site
      • Syracuse, New York, United States, 13202
        • Pfizer Investigational Site
      • Syracuse, New York, United States, 13210
        • Pfizer Investigational Site
      • Williamsville, New York, United States, 14221
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44126
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43214
        • Pfizer Investigational Site
    • Oregon
      • Keizer, Oregon, United States, 97303
        • Pfizer Investigational Site
      • Salem, Oregon, United States, 97302
        • Pfizer Investigational Site
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
      • Mt. Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
      • Mt. Pleasant, South Carolina, United States, 83464
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
      • Morristown, Tennessee, United States, 37813
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • McKinney, Texas, United States, 75069
        • 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:

  • Statin eligible per NCEP ATP-III guidelines
  • At least 18 years of age

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant
  • Intolerance to statin therapy
  • 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
Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.

Secondary Outcome Measures

Outcome Measure
Changes in levels of lipids and other biomarkers.

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

November 1, 2004

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

November 16, 2007

Last Update Submitted That Met QC Criteria

November 15, 2007

Last Verified

December 1, 2006

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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