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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00134485
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : October 30, 2007
Information provided by:

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia, Familial Hyperlipidemia Drug: torcetrapib/atorvastatin Drug: atorvastatin Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2005
Study Completion Date : March 2006

Primary Outcome Measures :
  1. Change in HDL-C and LDL-C

Secondary Outcome Measures :
  1. Changes in other lipid parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00134485

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United States, California
Pfizer Investigational Site
San Diego, California, United States, 92120
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
Pfizer Investigational Site
Lutz, Florida, United States, 33549
Pfizer Investigational Site
Tampa, Florida, United States, 33603
United States, Hawaii
Pfizer Investigational Site
Tripler AMC, Hawaii, United States, 96859-5000
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Iowa
Pfizer Investigational Site
Iowa City, Iowa, United States, 52242
United States, Maine
Pfizer Investigational Site
Auburn, Maine, United States, 04210
Pfizer Investigational Site
Scarborough, Maine, United States, 04074
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02111
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28204
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53719
Australia, New South Wales
Pfizer Investigational Site
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Pfizer Investigational Site
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Pfizer Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Pfizer Investigational Site
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Pfizer Investigational Site
Perth, Western Australia, Australia, 6000
Pfizer Investigational Site
Darlinghurst, Australia, NSW 2010
Canada, Quebec
Pfizer Investigational Site
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
Aalborg, Denmark, 9000
Pfizer Investigational Site
Arhus C, Denmark, 8000
Pfizer Investigational Site
Dijon, France, 21000
Pfizer Investigational Site
Nantes cedex 01, France, 44093
Pfizer Investigational Site
Paris, France, 75651 Cedex 13
Pfizer Investigational Site
Kopavogur, Iceland, 201
Pfizer Investigational Site
Oslo, Norway, 0027
Pfizer Investigational Site
Oslo, Norway, 0407
South Africa
Pfizer Investigational Site
Parow, Cape Town, South Africa, 7500
Pfizer Investigational Site
Bellville, Western Cape, South Africa, 7531
Pfizer Investigational Site
Bloemfontein, South Africa, 9301
Pfizer Investigational Site
Cape Town, South Africa, 7925
Pfizer Investigational Site
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
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Layout table for additonal information Identifier: NCT00134485    
Other Study ID Numbers: A5091026
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: October 30, 2007
Last Verified: December 2006
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors