Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia
Intervention: Torcetrapib/Atorvastatin (Drug); Fenofibrate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
Secondary outcome: Changes in levels of lipid parameters and other biomarkers
Detailed description:
For additional information please call: 1-800-718-1021
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Pfizer Investigational Site, Dijon 21000, France
Pfizer Investigational Site, Thouars 79100, France
Pfizer Investigational Site, Briollay 49125, France
Pfizer Investigational Site, Saint Martin D'Oney 40090, France
Pfizer Investigational Site, Mont de Marsan 40000, France
Pfizer Investigational Site, Strasbourg 67000, France
Pfizer Investigational Site, Jarny 54800, France
Pfizer Investigational Site, Metz 57070, France
Pfizer Investigational Site, Moutiers 54660, France
Pfizer Investigational Site, Bordeaux Cauderan 33 200, France
Pfizer Investigational Site, Tierce 49 125, France
Pfizer Investigational Site, Angers 49 100, France
Pfizer Investigational Site, Angers 49 000, France
Pfizer Investigational Site, Seysses 31600, France
Pfizer Investigational Site, Pouilly en Auxois 21 850, France
Pfizer Investigational Site, Nantes 44 093 Cedex 01, France
Pfizer Investigational Site, Mont de Marsan 40 010 cedex, France
Pfizer Investigational Site, Mont de Marsan CEDEX 40010, France
Pfizer Investigational Site, Mont de Marsan 40 010, France
Pfizer Investigational Site, Monguilhem 32 240, France
Pfizer Investigational Site, Saint Justin 40 240, France
Pfizer Investigational Site, Haut Mauco 40 280, France
Pfizer Investigational Site, Lille 59 037 Cedex, France
Pfizer Investigational Site, Murs Erigne 49610, France
Pfizer Investigational Site, Mars LA Tour 54800, France
Pfizer Investigational Site, Hagondange 57 300, France
Additional Information
Link to ClinicalStudyResults.org Posting:
Starting date: March 2005
Ending date: May 2006
Last updated: October 30, 2007
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