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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00139061

Collaborator

(none)

128

Enrollment

Locations

Duration (Months)

4.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemia	Drug: Torcetrapib/Atorvastatin Drug: Fenofibrate	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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

Study Start Date :

Mar 1, 2005

Study Completion Date :

May 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Pfizer Investigational Site	Angers	France	49 000
2	Pfizer Investigational Site	Angers	France	49 100
3	Pfizer Investigational Site	Bordeaux Cauderan	France	33 200
4	Pfizer Investigational Site	Briollay	France	49125
5	Pfizer Investigational Site	Dijon	France	21000
6	Pfizer Investigational Site	Hagondange	France	57 300
7	Pfizer Investigational Site	Haut Mauco	France	40 280
8	Pfizer Investigational Site	Jarny	France	54800
9	Pfizer Investigational Site	Lille	France	59 037 Cedex
10	Pfizer Investigational Site	Mars LA Tour	France	54800
11	Pfizer Investigational Site	Metz	France	57070
12	Pfizer Investigational Site	Monguilhem	France	32 240
13	Pfizer Investigational Site	Mont de Marsan CEDEX	France	40010
14	Pfizer Investigational Site	Mont de Marsan	France	40 010 cedex
15	Pfizer Investigational Site	Mont de Marsan	France	40 010
16	Pfizer Investigational Site	Mont de Marsan	France	40000
17	Pfizer Investigational Site	Moutiers	France	54660
18	Pfizer Investigational Site	Murs Erigne	France	49610
19	Pfizer Investigational Site	Nantes	France	44 093 Cedex 01
20	Pfizer Investigational Site	Pouilly en Auxois	France	21 850
21	Pfizer Investigational Site	Saint Justin	France	40 240
22	Pfizer Investigational Site	Saint Martin D'Oney	France	40090
23	Pfizer Investigational Site	Seysses	France	31600
24	Pfizer Investigational Site	Strasbourg	France	67000
25	Pfizer Investigational Site	Thouars	France	79100
26	Pfizer Investigational Site	Tierce	France	49 125