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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139061
• Other study ID #: A5091034
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2005
• Last updated: October 30, 2007
• Start date: March 2005
• Est. completion date: May 2006

Study information

• Verified date: December 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Torcetrapib/Atorvastatin

• Fenofibrate

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Angers
France	Pfizer Investigational Site	Angers
France	Pfizer Investigational Site	Bordeaux Cauderan
France	Pfizer Investigational Site	Briollay
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Hagondange
France	Pfizer Investigational Site	Haut Mauco
France	Pfizer Investigational Site	Jarny
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Mars LA Tour
France	Pfizer Investigational Site	Metz
France	Pfizer Investigational Site	Monguilhem
France	Pfizer Investigational Site	Mont de Marsan
France	Pfizer Investigational Site	Mont de Marsan
France	Pfizer Investigational Site	Mont de Marsan
France	Pfizer Investigational Site	Mont de Marsan CEDEX
France	Pfizer Investigational Site	Moutiers
France	Pfizer Investigational Site	Murs Erigne
France	Pfizer Investigational Site	Nantes
France	Pfizer Investigational Site	Pouilly en Auxois
France	Pfizer Investigational Site	Saint Justin
France	Pfizer Investigational Site	Saint Martin D'Oney
France	Pfizer Investigational Site	Seysses
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Thouars
France	Pfizer Investigational Site	Tierce

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
Secondary	Changes in levels of lipid parameters and other biomarkers