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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139061
First received: August 26, 2005
Last updated: October 30, 2007
Last verified: December 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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
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, 40000
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 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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

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

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Atorvastatin
Torcetrapib
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014