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

NCT ID: NCT00134485

Last Updated: 2007-10-30

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-03-31

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 torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

Detailed Description

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

Conditions

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Hypercholesterolemia, Familial Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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torcetrapib/atorvastatin

Intervention Type DRUG

atorvastatin

Intervention Type DRUG

Eligibility Criteria

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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
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

San Diego, California, United States

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Washington D.C., District of Columbia, United States

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Lutz, Florida, United States

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Tampa, Florida, United States

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Tripler AMC, Hawaii, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Auburn, Maine, United States

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Scarborough, Maine, United States

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Boston, Massachusetts, United States

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Charlotte, North Carolina, United States

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Houston, Texas, United States

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Madison, Wisconsin, United States

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Camperdown, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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North Adelaide, South Australia, Australia

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Clayton, Victoria, Australia

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Perth, Western Australia, Australia

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Darlinghurst, , Australia

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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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Ste-Foy, Quebec, Canada

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Aalborg, , Denmark

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Arhus C, , Denmark

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Dijon, , France

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Nantes, , France

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Paris, , France

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Kopavogur, , Iceland

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Oslo, , Norway

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Oslo, , Norway

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Parow, Cape Town, South Africa

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Bellville, Western Cape, South Africa

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Gothenburg, , Sweden

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Linköping, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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, ,

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Countries

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United States Australia Canada Denmark France Iceland Norway South Africa Sweden

Other Identifiers

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A5091026

Identifier Type: -

Identifier Source: org_study_id