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

NCT ID: NCT00134511

Last Updated: 2007-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-11-30

Brief Summary

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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

Detailed Description

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

Conditions

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Hypercholesterolemia, Familial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Torcetrapib/atorvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Homozygous Familial Hypercholesterolemia

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Chicoutimi, Quebec, Canada

Site Status

Pfizer Investigational Site

Ste-Foy, Quebec, Canada

Site Status

Pfizer Investigational Site

Parktown, Johannesburg, South Africa

Site Status

Pfizer Investigational Site

Bloemfontein, , South Africa

Site Status

Pfizer Investigational Site

Cape Town, , South Africa

Site Status

Countries

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United States Canada South Africa

Other Identifiers

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A5091027

Identifier Type: -

Identifier Source: org_study_id