Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia

October 28, 2007 updated by: Pfizer

Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia

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

To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment

400

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

        • Pfizer Investigational Site
  • Australia
      • Darlinghurst, Australia, NSW 2010
        • Pfizer Investigational Site
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Pfizer Investigational Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Pfizer Investigational Site
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Pfizer Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Pfizer Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Pfizer Investigational Site
  • Canada
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2W 1R7
        • Pfizer Investigational Site
      • Ste-Foy, Quebec, Canada, G1V 4M6
        • Pfizer Investigational Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Pfizer Investigational Site
      • Arhus C, Denmark, 8000
        • Pfizer Investigational Site
  • France
      • Dijon, France, 21000
        • Pfizer Investigational Site
      • Nantes cedex 01, France, 44093
        • Pfizer Investigational Site
      • Paris, France, 75651 Cedex 13
        • Pfizer Investigational Site
  • Iceland
      • Kopavogur, Iceland, 201
        • Pfizer Investigational Site
  • Norway
      • Oslo, Norway, 0407
        • Pfizer Investigational Site
      • Oslo, Norway, 0027
        • Pfizer Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7925
        • Pfizer Investigational Site
    • Cape Town
      • Parow, Cape Town, South Africa, 7500
        • Pfizer Investigational Site
    • Western Cape
      • Bellville, Western Cape, South Africa, 7531
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 413 45
        • Pfizer Investigational Site
      • Linkoping, Sweden, 581 85
        • Pfizer Investigational Site
      • Malmo, Sweden, 205 02
        • Pfizer Investigational Site
      • Stockholm, Sweden, 141 86
        • Pfizer Investigational Site
  • United States
    • California
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Pfizer Investigational Site
    • Florida
      • Lutz, Florida, United States, 33549
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33603
        • Pfizer Investigational Site
    • Hawaii
      • Tripler AMC, Hawaii, United States, 96859-5000
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Pfizer Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Pfizer Investigational Site
      • Scarborough, Maine, United States, 04074
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53719
        • 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:

  • Diagnosis of Heterozygous Familial Hypercholesterolemia
  • At least 18 years of age

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid (high doses)
  • 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 HDL-C and LDL-C

Secondary Outcome Measures

Outcome Measure
Changes in other lipid parameters

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

March 1, 2005

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

October 30, 2007

Last Update Submitted That Met QC Criteria

October 28, 2007

Last Verified

December 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5091026

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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