Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate

NCT ID: NCT00139061

Last Updated: 2007-10-31

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

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-05-31

Brief Summary

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

To assess the HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.

Detailed Description

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

Conditions

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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

Fenofibrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Fredrickson Type IIB dyslipidema (Mixed Hyperlipidemia)
* Men and women 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
* 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

Angers, , France

Site Status

Pfizer Investigational Site

Angers, , France

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Pfizer Investigational Site

Bordeaux Cauderan, , France

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Pfizer Investigational Site

Briollay, , France

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Pfizer Investigational Site

Dijon, , France

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Pfizer Investigational Site

Hagondange, , France

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Pfizer Investigational Site

Haut-Mauco, , France

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Pfizer Investigational Site

Jarny, , France

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Pfizer Investigational Site

Lille, , France

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Pfizer Investigational Site

Mars-la-Tour, , France

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Pfizer Investigational Site

Metz, , France

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Pfizer Investigational Site

Monguilhem, , France

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Pfizer Investigational Site

Mont-de-Marsan, , France

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Pfizer Investigational Site

Mont-de-Marsan, , France

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Pfizer Investigational Site

Mont-de-Marsan, , France

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Pfizer Investigational Site

Mont-de-Marsan, , France

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Pfizer Investigational Site

Moûtiers, , France

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Pfizer Investigational Site

Mûrs-Erigné, , France

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Pfizer Investigational Site

Nantes, , France

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Pfizer Investigational Site

Pouilly-en-Auxois, , France

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Pfizer Investigational Site

Saint-Justin, , France

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Pfizer Investigational Site

Saint-Martin-d'Oney, , France

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Pfizer Investigational Site

Seysses, , France

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Pfizer Investigational Site

Strasbourg, , France

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Pfizer Investigational Site

Thouars, , France

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Pfizer Investigational Site

Tiercé, , France

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Countries

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France

Other Identifiers

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A5091034

Identifier Type: -

Identifier Source: org_study_id