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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00139061

Purpose

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.

Condition	Intervention	Phase
Hyperlipidemia	Drug: Torcetrapib/Atorvastatin Drug: Fenofibrate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Forced Titration Study Of The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Compared To Fenofibrate In Subjects With Fredrickson Type IIB Dyslipidemia (Mixed Hyperlipidemia

Resource links provided by NLM:

Drug Information available for: Procetofen Atorvastatin Atorvastatin calcium Torcetrapib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Changes in levels of lipid parameters and other biomarkers

Estimated Enrollment:	128
Study Start Date:	March 2005
Estimated Study Completion Date:	May 2006

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139061

Locations

France
Pfizer Investigational Site
Dijon, France, 21000
Pfizer Investigational Site
Thouars, France, 79100
Pfizer Investigational Site
Briollay, France, 49125
Pfizer Investigational Site
Saint Martin D'Oney, France, 40090
Pfizer Investigational Site
Mont de Marsan, France, 40000
Pfizer Investigational Site
Strasbourg, France, 67000
Pfizer Investigational Site
Jarny, France, 54800
Pfizer Investigational Site
Metz, France, 57070
Pfizer Investigational Site
Moutiers, France, 54660
Pfizer Investigational Site
Bordeaux Cauderan, France, 33 200
Pfizer Investigational Site
Tierce, France, 49 125
Pfizer Investigational Site
Angers, France, 49 100
Pfizer Investigational Site
Angers, France, 49 000
Pfizer Investigational Site
Hagondange, France, 57 300
Pfizer Investigational Site
Pouilly en Auxois, France, 21 850
Pfizer Investigational Site
Nantes, France, 44 093 Cedex 01
Pfizer Investigational Site
Mont de Marsan, France, 40 010 cedex
Pfizer Investigational Site
Mont de Marsan CEDEX, France, 40010
Pfizer Investigational Site
Mont de Marsan, France, 40 010
Pfizer Investigational Site
Monguilhem, France, 32 240
Pfizer Investigational Site
Saint Justin, France, 40 240
Pfizer Investigational Site
Haut Mauco, France, 40 280
Pfizer Investigational Site
Lille, France, 59 037 Cedex
Pfizer Investigational Site
Murs Erigne, France, 49610
Pfizer Investigational Site
Mars LA Tour, France, 54800
Pfizer Investigational Site
Seysses, France, 31600

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A5091034
Study First Received:	August 26, 2005
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00139061 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Procetofen
Pharmacologic Actions
Torcetrapib
Therapeutic Uses
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010