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

NCT ID: NCT00145431

Last Updated: 2012-02-17

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-12-31

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 subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.

Detailed Description

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

Conditions

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Hyperlipoproteinemia Type III

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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torcetrapib/atorvastatin

Intervention Type DRUG

atorvastatin

Intervention Type DRUG

fenofibrate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Anaheim, California, United States

Site Status

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Huntington Beach, California, United States

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Orange, California, United States

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Pacific Palisades, California, United States

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Studio City, California, United States

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Tustin, California, United States

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Hollywood, Florida, United States

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Longwood, Florida, United States

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Tripler Army Medical Center, Hawaii, United States

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Scarborough, Maine, United States

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Portage, Michigan, United States

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Portage, Michigan, United States

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Olive Branch, Mississippi, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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West Seneca, New York, United States

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Sellersville, Pennsylvania, United States

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Greer, South Carolina, United States

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Memphis, Tennessee, United States

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Salt Lake City, Utah, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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London, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Countries

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United States Canada

Other Identifiers

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A5091024

Identifier Type: -

Identifier Source: org_study_id

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