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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00145431
First received: August 31, 2005
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Hyperlipoproteinemia Type III
Drug: torcetrapib/atorvastatin
Drug: atorvastatin
Drug: fenofibrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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).

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

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

Enrollment: 41
Study Start Date: March 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145431

  Hide Study Locations
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, H2W 1R7
Pfizer Investigational Site
Montreal, Quebec, Canada, H1T 1C8
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 4M6
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00145431     History of Changes
Other Study ID Numbers: A5091024
Study First Received: August 31, 2005
Last Updated: February 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperlipoproteinemias
Hyperlipoproteinemia Type III
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Fenofibrate
Atorvastatin
Torcetrapib
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014