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

Condition	Intervention	Phase
Hyperlipidemia	Drug: Torcetrapib/Atorvastatin  Drug: Fenofibrate	Phase III

Further Study Details: 

Primary Outcomes: To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
Secondary Outcomes: Changes in levels of lipid parameters and other biomakers
Expected Total Enrollment:  128

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 evaluationof response, or render unlikely that the subject would complete the study

Please refer to this study by ClinicalTrials.gov identifier  NCT00139061

Pfizer CT.gov Call Center      1-800-718-1021 

France
      Pfizer Investigational Site, Dijon,  21000,  France; Recruiting
      Pfizer Investigational Site, Thouars,  79100,  France; Recruiting
      Pfizer Investigational Site, Briollay,  49125,  France; Recruiting
      Pfizer Investigational Site, Saint-Martin-d''''Oney,  40090,  France; Recruiting
      Pfizer Investigational Site, Mont-de-Marsan,  40000,  France; Recruiting
      Pfizer Investigational Site, Strasbourg,  67000,  France; Recruiting
      Pfizer Investigational Site, Jarny,  54800,  France; Recruiting
      Pfizer Investigational Site, Metz,  57070,  France; Recruiting
      Pfizer Investigational Site, Moutiers,  54660,  France; Recruiting
      Pfizer Investigational Site, Bordeaux Caudéran,  33 200,  France; Recruiting
      Pfizer Investigational Site, Tiercé,  49 125,  France; Recruiting
      Pfizer Investigational Site, Angers,  49 100,  France; Recruiting
      Pfizer Investigational Site, Angers,  49 000,  France; Recruiting
      Pfizer Investigational Site, Angers,  49 000,  France; Recruiting
      Pfizer Investigational Site, Seysses,  31600,  France; Recruiting
      Pfizer Investigational Site, Angers,  49 100,  France; Recruiting
      Pfizer Investigational Site, Angers,  49 000,  France; Recruiting
      Pfizer Investigational Site, Pouilly-en-Auxois,  21 850,  France; Recruiting
      Pfizer Investigational Site, Nantes,  44 093 Cedex 01,  France; Recruiting
      Pfizer Investigational Site, Mont-de-Marsan,  40 010 cedex,  France; Recruiting
      Pfizer Investigational Site, Mont de Marsan CEDEX,  40010,  France; Recruiting
      Pfizer Investigational Site, Mont-de-Marsan,  40 010,  France; Recruiting
      Pfizer Investigational Site, Monguilhem,  32 240,  France; Recruiting
      Pfizer Investigational Site, Saint-Justin,  40 240,  France; No longer recruiting
      Pfizer Investigational Site, Haut-Mauco,  40 280,  France; Recruiting
      Pfizer Investigational Site, Lille,  59 037 Cedex,  France; Recruiting
      Pfizer Investigational Site, Murs-Erigne,  49610,  France; Recruiting
      Pfizer Investigational Site, Mars-la-Tour,  54800,  France; Recruiting
      Pfizer Investigational Site, Hagondange,  57 300,  France; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A5091034
Last Updated:  August 30, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00139061
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06