A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides

NCT ID: NCT00134498

Last Updated: 2007-11-16

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-11-30

Brief Summary

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The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.

Detailed Description

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

Conditions

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Hypertriglyceridemia Hyperlipoproteinemia Type IV

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 Fredrickson Type IV Hypertriglyceridemia

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

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

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Huntington Beach, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Orangevale, 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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Walnut Creek, California, United States

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Farmington, Connecticut, United States

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

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Hollywood, Florida, United States

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Longwood, Florida, United States

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West Palm Beach, 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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Overland Park, Kansas, United States

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Baton Rouge, Louisiana, United States

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Scarborough, Maine, United States

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Bethesda, Maryland, United States

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Ann Arbor, Michigan, United States

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Canton, Michigan, United States

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Portage, Michigan, United States

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Richland, Michigan, United States

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Saint Cloud, Minnesota, United States

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Olive Branch, Mississippi, United States

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Jefferson City, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, 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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Statesville, North Carolina, United States

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Sellersville, Pennsylvania, United States

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Warwick, Rhode Island, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Madison, Wisconsin, United States

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Halifax, Nova Scotia, Canada

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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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Ste-Foy, Quebec, Canada

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Countries

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United States Canada

Related Links

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Other Identifiers

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A5091025

Identifier Type: -

Identifier Source: org_study_id