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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00134485
First received: August 22, 2005
Last updated: October 28, 2007
Last verified: December 2006
  Purpose

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 Intervention Phase
Hypercholesterolemia, Familial
Hyperlipidemia
Drug: torcetrapib/atorvastatin
Drug: atorvastatin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • Changes in other lipid parameters

Estimated Enrollment: 400
Study Start Date: March 2005
Estimated Study Completion Date: March 2006
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 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
  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: NCT00134485

  Hide Study Locations
Locations
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
Australia
Pfizer Investigational Site
Darlinghurst, Australia, NSW 2010
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
Pfizer Investigational Site
Ste-Foy, Quebec, Canada, G1V 4M6
Denmark
Pfizer Investigational Site
Aalborg, Denmark, 9000
Pfizer Investigational Site
Arhus C, Denmark, 8000
France
Pfizer Investigational Site
Unknown, Lille, France, 59037
Pfizer Investigational Site
Dijon, France, 21000
Pfizer Investigational Site
Nantes cedex 01, France, 44093
Pfizer Investigational Site
Paris, France, 75651 Cedex 13
Iceland
Pfizer Investigational Site
Kopavogur, Iceland, 201
Norway
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
Sweden
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00134485     History of Changes
Other Study ID Numbers: A5091026
Study First Received: August 22, 2005
Last Updated: October 28, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014