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CompletedNCT00134511Updated Nov 7, 2007

Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder

A Phase 3 interventional study of Torcetrapib/atorvastatin in Hypercholesterolemia, Familial, sponsored by Pfizer. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-07.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Non-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 the lipid drug Torcetrapib/atorvastatin in patients with genetically known disorder of extremely high cholesterol

Read the detailed description

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

02

Conditions studied

  • Hypercholesterolemia, Familial
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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 30 is below 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 Homozygous Familial Hypercholesterolemia

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
  • 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 evaluationof response, or render unlikely that the subject would complete the study
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants

Interventions

  • DrugTorcetrapib/atorvastatin
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What researchers measure

Primary outcomes

  1. Change in LDL-C and HDL-C

Secondary outcomes

  1. Other lipid variables

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Study locations

6 sites
  • Pfizer Investigational Site
    Boston, Massachusetts 02114, United States
  • Pfizer Investigational Site
    Chicoutimi, Quebec G7H 5H6, Canada
  • Pfizer Investigational Site
    Ste-Foy, Quebec G1V 4M6, Canada
  • Pfizer Investigational Site
    Parktown, Johannesburg 2193, South Africa
  • Pfizer Investigational Site
    Bloemfontein, 9301, South Africa
  • Pfizer Investigational Site
    Cape Town, 7925, South Africa
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00134511
Lead sponsor
Pfizer
First posted
Aug 24, 2005
Start date
Mar 2005
Completion
Nov 2005
Last update
Nov 7, 2007

Study contacts

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

Not currently enrolling

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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