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CompletedNCT00134485Updated Oct 30, 2007

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

A Phase 3 interventional study of torcetrapib/atorvastatin and atorvastatin in Hypercholesterolemia, Familial and Hyperlipidemia, sponsored by Pfizer. Completed at 41 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-10-30.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

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

02

Conditions studied

  • Hypercholesterolemia, Familial
  • Hyperlipidemia
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In context

Hyperlipoproteinemia Type II

245 studies on the registry are indexed under Hyperlipoproteinemia Type II; 52 are open to participants now.

This study's enrollment of 400 is above the median of 86 across 170 interventional studies indexed under Hyperlipoproteinemia Type II.

Browse Hyperlipoproteinemia Type II studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of Heterozygous Familial Hypercholesterolemia
  • At least 18 years of age

Exclusion criteria

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
400 participants

Interventions

  • Drugtorcetrapib/atorvastatin
  • Drugatorvastatin
06

What researchers measure

Primary outcomes

  1. Change in HDL-C and LDL-C

Secondary outcomes

  1. Changes in other lipid parameters

07

Study locations

41 sites
  • Pfizer Investigational Site
    San Diego, California 92120, United States
  • Pfizer Investigational Site
    Washington, District of Columbia 20037, United States
  • Pfizer Investigational Site
    Lutz, Florida 33549, United States
  • Pfizer Investigational Site
    Tampa, Florida 33603, United States
  • Pfizer Investigational Site
    Tripler AMC, Hawaii 96859-5000, United States
  • Pfizer Investigational Site
    Chicago, Illinois 60610, United States
  • Pfizer Investigational Site
    Indianapolis, Indiana 46260, United States
  • Pfizer Investigational Site
    Iowa City, Iowa 52242, United States
  • Pfizer Investigational Site
    Auburn, Maine 04210, United States
  • Pfizer Investigational Site
    Scarborough, Maine 04074, United States
  • Pfizer Investigational Site
    Boston, Massachusetts 02111, United States
  • Pfizer Investigational Site
    Charlotte, North Carolina 28204, United States
  • Pfizer Investigational Site
    Houston, Texas 77030, United States
  • Pfizer Investigational Site
    Madison, Wisconsin 53719, United States
  • Pfizer Investigational Site
    Camperdown, New South Wales 2050, Australia
  • Pfizer Investigational Site
    Woolloongabba, Queensland 4102, Australia
  • Pfizer Investigational Site
    North Adelaide, South Australia 5006, Australia
  • Pfizer Investigational Site
    Clayton, Victoria 3168, Australia
  • Pfizer Investigational Site
    Perth, Western Australia 6000, Australia
  • Pfizer Investigational Site
    Darlinghurst, NSW 2010, Australia
  • Pfizer Investigational Site
    Chicoutimi, Quebec G7H 5H6, Canada
  • Pfizer Investigational Site
    Montreal, Quebec H1T 1C8, Canada
  • Pfizer Investigational Site
    Montreal, Quebec H2W 1R7, Canada
  • Pfizer Investigational Site
    Ste-Foy, Quebec G1V 4M6, Canada
  • Pfizer Investigational Site
    Aalborg, 9000, Denmark
  • Pfizer Investigational Site
    Arhus C, 8000, Denmark
  • Pfizer Investigational Site
    Dijon, 21000, France
  • Pfizer Investigational Site
    Nantes cedex 01, 44093, France
  • Pfizer Investigational Site
    Paris, 75651 Cedex 13, France
  • Pfizer Investigational Site
    Kopavogur, 201, Iceland
  • Pfizer Investigational Site
    Oslo, 0027, Norway
  • Pfizer Investigational Site
    Oslo, 0407, Norway
  • Pfizer Investigational Site
    Parow, Cape Town 7500, South Africa
  • Pfizer Investigational Site
    Bellville, Western Cape 7531, South Africa
  • Pfizer Investigational Site
    Bloemfontein, 9301, South Africa
  • Pfizer Investigational Site
    Cape Town, 7925, South Africa
  • Pfizer Investigational Site
    Goteborg, 413 45, Sweden
  • Pfizer Investigational Site
    Linkoping, 581 85, Sweden
  • Pfizer Investigational Site
    Malmo, 205 02, Sweden
  • Pfizer Investigational Site
    Stockholm, 141 86, Sweden
  • Pfizer Investigational Site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00134485
Lead sponsor
Pfizer
First posted
Aug 24, 2005
Start date
Mar 2005
Completion
Mar 2006
Last update
Oct 30, 2007

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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