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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: Fenofibrate; Drug: Torcetrapib/Atorvastatin

Detailed Description

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

• Study Type: Interventional
• Enrollment: 128
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Changes in levels of lipid parameters and other biomarkers

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Study Completion: May 1, 2006

Study Registration Dates

• First Submitted: August 26, 2005
• First Submitted That Met QC Criteria: August 26, 2005
• First Posted (ESTIMATE): August 30, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2007
• Last Update Submitted That Met QC Criteria: October 30, 2007
• Last Verified: December 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Fenofibrate; Torcetrapib
• Other Study ID Numbers: A5091034