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A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides

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.
 
ClinicalTrials.gov Identifier: NCT00134498
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : November 16, 2007
Sponsor:
Information provided by:
Pfizer

Brief Summary:

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

To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.


Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Hyperlipoproteinemia Type IV 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 : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia
Study Start Date : February 2005
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides




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

Secondary Outcome Measures :
  1. Changes in levels of other lipid and biomarkers.


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
Criteria

Inclusion Criteria:

  • Diagnosis of Fredrickson Type IV Hypertriglyceridemia

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 ClinicalTrials.gov identifier (NCT number): NCT00134498


Locations
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United States, California
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Huntington Beach, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Orangevale, California, United States
Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
Pacific Palisades, California, United States
Pfizer Investigational Site
Studio City, California, United States
Pfizer Investigational Site
Tustin, California, United States
Pfizer Investigational Site
Walnut Creek, California, United States
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States
United States, Florida
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Longwood, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
United States, Hawaii
Pfizer Investigational Site
Tripler AMC, Hawaii, United States
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States
United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States
United States, Maine
Pfizer Investigational Site
Scarborough, Maine, United States
United States, Maryland
Pfizer Investigational Site
Bethesda, Maryland, United States
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
Canton, Michigan, United States
Pfizer Investigational Site
Portage, Michigan, United States
Pfizer Investigational Site
Richland, Michigan, United States
United States, Minnesota
Pfizer Investigational Site
St. Cloud, Minnesota, United States
United States, Mississippi
Pfizer Investigational Site
Olive Branch, Mississippi, United States
United States, Missouri
Pfizer Investigational Site
Jefferson City, Missouri, United States
Pfizer Investigational Site
St. Louis, Missouri, United States
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States
United States, New York
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Syracuse, New York, United States
Pfizer Investigational Site
West Seneca, New York, United States
United States, North Carolina
Pfizer Investigational Site
Statesville, North Carolina, United States
United States, Pennsylvania
Pfizer Investigational Site
Sellersville, Pennsylvania, United States
United States, Rhode Island
Pfizer Investigational Site
Warwick, Rhode Island, United States
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada
Canada, Quebec
Pfizer Investigational Site
Chicoutimi, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Ste-Foy, Quebec, Canada
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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ClinicalTrials.gov Identifier: NCT00134498    
Other Study ID Numbers: A5091025
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: November 16, 2007
Last Verified: March 2007
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type IV
Hypertriglyceridemia
Hyperlipoproteinemias
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Atorvastatin
Torcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors