Clinical trial NCT00139061: Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility 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

Primary outcomes:
measure: To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
Secondary outcomes:
measure: Changes in levels of lipid parameters and other biomarkers
Other outcomes:
Locations:
city: Angers
country: France
facility: Pfizer Investigational Site
city: Angers
country: France
facility: Pfizer Investigational Site
city: Bordeaux Cauderan
country: France
facility: Pfizer Investigational Site
city: Briollay
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Hagondange
country: France
facility: Pfizer Investigational Site
city: Haut Mauco
country: France
facility: Pfizer Investigational Site
city: Jarny
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Mars LA Tour
country: France
facility: Pfizer Investigational Site
city: Metz
country: France
facility: Pfizer Investigational Site
city: Monguilhem
country: France
facility: Pfizer Investigational Site
city: Mont de Marsan CEDEX
country: France
facility: Pfizer Investigational Site
city: Mont de Marsan
country: France
facility: Pfizer Investigational Site
city: Mont de Marsan
country: France
facility: Pfizer Investigational Site
city: Mont de Marsan
country: France
facility: Pfizer Investigational Site
city: Moutiers
country: France
facility: Pfizer Investigational Site
city: Murs Erigne
country: France
facility: Pfizer Investigational Site
city: Nantes
country: France
facility: Pfizer Investigational Site
city: Pouilly en Auxois
country: France
facility: Pfizer Investigational Site
city: Saint Justin
country: France
facility: Pfizer Investigational Site
city: Saint Martin D'Oney
country: France
facility: Pfizer Investigational Site
city: Seysses
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Thouars
country: France
facility: Pfizer Investigational Site
city: Tierce
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: