NCT00139061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

October 31, 2007

Status Verified

December 1, 2006

First QC Date

August 26, 2005

Last Update Submit

October 30, 2007

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.

Secondary Outcomes (1)

  • Changes in levels of lipid parameters and other biomarkers

Interventions

Torcetrapib/AtorvastatinDRUG
FenofibrateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Fredrickson Type IIB dyslipidema (Mixed Hyperlipidemia)
  • Men and women at least 18 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Pfizer Investigational Site

Angers, 49 000, France

Location

Pfizer Investigational Site

Angers, 49 100, France

Location

Pfizer Investigational Site

Bordeaux Cauderan, 33 200, France

Location

Pfizer Investigational Site

Briollay, 49125, France

Location

Pfizer Investigational Site

Dijon, 21000, France

Location

Pfizer Investigational Site

Hagondange, 57 300, France

Location

Pfizer Investigational Site

Haut-Mauco, 40 280, France

Location

Pfizer Investigational Site

Jarny, 54800, France

Location

Pfizer Investigational Site

Lille, 59 037 Cedex, France

Location

Pfizer Investigational Site

Mars-la-Tour, 54800, France

Location

Pfizer Investigational Site

Metz, 57070, France

Location

Pfizer Investigational Site

Monguilhem, 32 240, France

Location

Pfizer Investigational Site

Mont-de-Marsan, 40 010 cedex, France

Location

Pfizer Investigational Site

Mont-de-Marsan, 40 010, France

Location

Pfizer Investigational Site

Mont-de-Marsan, 40000, France

Location

Pfizer Investigational Site

Mont-de-Marsan, 40010, France

Location

Pfizer Investigational Site

Moûtiers, 54660, France

Location

Pfizer Investigational Site

Mûrs-Erigné, 49610, France

Location

Pfizer Investigational Site

Nantes, 44 093 Cedex 01, France

Location

Pfizer Investigational Site

Pouilly-en-Auxois, 21 850, France

Location

Pfizer Investigational Site

Saint-Justin, 40 240, France

Location

Pfizer Investigational Site

Saint-Martin-d'Oney, 40090, France

Location

Pfizer Investigational Site

Seysses, 31600, France

Location

Pfizer Investigational Site

Strasbourg, 67000, France

Location

Pfizer Investigational Site

Thouars, 79100, France

Location

Pfizer Investigational Site

Tiercé, 49 125, France

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

torcetrapibAtorvastatinFenofibrate

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsFibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 30, 2005

Study Start

March 1, 2005

Study Completion

May 1, 2006

Last Updated

October 31, 2007

Record last verified: 2006-12

Locations

FR(26)