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

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Torcetrapib/Atorvastatin
Fenofibrate
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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

Full Information

First Posted
August 26, 2005
Last Updated
October 30, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00139061
Brief Title
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

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. 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.
Detailed Description
For additional information please call: 1-800-718-1021

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
128 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Torcetrapib/Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Primary Outcome Measure Information:
Title
To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
Secondary Outcome Measure Information:
Title
Changes in levels of lipid parameters and other biomarkers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Angers
ZIP/Postal Code
49 000
Country
France
Facility Name
Pfizer Investigational Site
City
Angers
ZIP/Postal Code
49 100
Country
France
Facility Name
Pfizer Investigational Site
City
Bordeaux Cauderan
ZIP/Postal Code
33 200
Country
France
Facility Name
Pfizer Investigational Site
City
Briollay
ZIP/Postal Code
49125
Country
France
Facility Name
Pfizer Investigational Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Pfizer Investigational Site
City
Hagondange
ZIP/Postal Code
57 300
Country
France
Facility Name
Pfizer Investigational Site
City
Haut Mauco
ZIP/Postal Code
40 280
Country
France
Facility Name
Pfizer Investigational Site
City
Jarny
ZIP/Postal Code
54800
Country
France
Facility Name
Pfizer Investigational Site
City
Lille
ZIP/Postal Code
59 037 Cedex
Country
France
Facility Name
Pfizer Investigational Site
City
Mars LA Tour
ZIP/Postal Code
54800
Country
France
Facility Name
Pfizer Investigational Site
City
Metz
ZIP/Postal Code
57070
Country
France
Facility Name
Pfizer Investigational Site
City
Monguilhem
ZIP/Postal Code
32 240
Country
France
Facility Name
Pfizer Investigational Site
City
Mont de Marsan CEDEX
ZIP/Postal Code
40010
Country
France
Facility Name
Pfizer Investigational Site
City
Mont de Marsan
ZIP/Postal Code
40 010 cedex
Country
France
Facility Name
Pfizer Investigational Site
City
Mont de Marsan
ZIP/Postal Code
40 010
Country
France
Facility Name
Pfizer Investigational Site
City
Mont de Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
Pfizer Investigational Site
City
Moutiers
ZIP/Postal Code
54660
Country
France
Facility Name
Pfizer Investigational Site
City
Murs Erigne
ZIP/Postal Code
49610
Country
France
Facility Name
Pfizer Investigational Site
City
Nantes
ZIP/Postal Code
44 093 Cedex 01
Country
France
Facility Name
Pfizer Investigational Site
City
Pouilly en Auxois
ZIP/Postal Code
21 850
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Justin
ZIP/Postal Code
40 240
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Martin D'Oney
ZIP/Postal Code
40090
Country
France
Facility Name
Pfizer Investigational Site
City
Seysses
ZIP/Postal Code
31600
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Pfizer Investigational Site
City
Thouars
ZIP/Postal Code
79100
Country
France
Facility Name
Pfizer Investigational Site
City
Tierce
ZIP/Postal Code
49 125
Country
France

12. IPD Sharing Statement

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

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