Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Subjects With A Genetic Cholesterol Disorder.

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: NCT00145431
Recruitment Status : Terminated
First Posted : September 5, 2005
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):

Brief Summary:

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

To evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.

Condition or disease Intervention/treatment Phase
Hyperlipoproteinemia Type III Drug: torcetrapib/atorvastatin Drug: atorvastatin Drug: fenofibrate Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3, Multi-Center, Double-Blind, Randomized, Crossover Study Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (Cp-529,414)/Atorvastatin, Compared With Atorvastatin Therapy Alone, And Fenofibrate Alone, In Subjects With Fredrickson Type III Hyperlipoproteinemia (Familial Dysbetalipoproteinemia).
Study Start Date : March 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

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

Secondary Outcome Measures :
  1. Changes in other lipid and biomarker variable levels.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia)

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
  • 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): NCT00145431

  Hide Study Locations
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92804
Pfizer Investigational Site
Huntington Beach, California, United States, 92648
Pfizer Investigational Site
Orange, California, United States, 92868
Pfizer Investigational Site
Pacific Palisades, California, United States, 90272
Pfizer Investigational Site
Studio City, California, United States, 91604
Pfizer Investigational Site
Tustin, California, United States, 92780
United States, Florida
Pfizer Investigational Site
Hollywood, Florida, United States, 33021
Pfizer Investigational Site
Longwood, Florida, United States, 32779
United States, Hawaii
Pfizer Investigational Site
Tripler Army Medical Center, Hawaii, United States, 96859-5000
United States, Maine
Pfizer Investigational Site
Scarborough, Maine, United States, 04074
United States, Michigan
Pfizer Investigational Site
Portage, Michigan, United States, 49002
Pfizer Investigational Site
Portage, Michigan, United States, 49024
United States, Mississippi
Pfizer Investigational Site
Olive Branch, Mississippi, United States, 38654
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14618
Pfizer Investigational Site
Syracuse, New York, United States, 13210
Pfizer Investigational Site
West Seneca, New York, United States, 14224
United States, Pennsylvania
Pfizer Investigational Site
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38105
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84108
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53719
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6A 5K8
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
Quebec, Canada, G1V 4M6
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Responsible Party: Pfizer Identifier: NCT00145431     History of Changes
Other Study ID Numbers: A5091024
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Hyperlipoproteinemia Type III
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors