To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastain alone in patients with heterozygous familial hypercholesterolemia

Condition	Intervention	Phase
Hypercholesterolemia, Familial Hyperlipidemia	Drug: torcetrapib/atorvastatin  Drug: atorvastatin	Phase III

Further Study Details: 

Primary Outcomes: Change in HDL-C and LDL-C
Secondary Outcomes: Changes in other lipid parameters
Expected Total Enrollment:  400

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

Criteria

Inclusion Criteria:

• Diagnosis of Heterozygous Familial Hypercholesterolemia
• 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 (high doses)
• 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  NCT00134485

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

California
      Pfizer Investigational Site, San Diego,  California,  92120,  United States; No longer recruiting
District of Columbia
      Pfizer Investigational Site, Washington,  District of Columbia,  20037,  United States; Recruiting
Florida
      Pfizer Investigational Site, Lutz,  Florida,  33549,  United States; Recruiting
      Pfizer Investigational Site, Tampa,  Florida,  33603,  United States; Recruiting
Hawaii
      Pfizer Investigational Site, Tripler AMC,  Hawaii,  96859-5000,  United States; Recruiting
Illinois
      Pfizer Investigational Site, Chicago,  Illinois,  60610,  United States; Recruiting
Indiana
      Pfizer Investigational Site, Indianapolis,  Indiana,  46260,  United States; Recruiting
Iowa
      Pfizer Investigational Site, Iowa City,  Iowa,  52242,  United States; Recruiting
Maine
      Pfizer Investigational Site, Scarborough,  Maine,  04074,  United States; Recruiting
      Pfizer Investigational Site, Auburn,  Maine,  04210,  United States; Recruiting
Massachusetts
      Pfizer Investigational Site, Boston,  Massachusetts,  02111,  United States; Recruiting
North Carolina
      Pfizer Investigational Site, Charlotte,  North Carolina,  28204,  United States; Recruiting
Texas
      Pfizer Investigational Site, Houston,  Texas,  77030,  United States; Recruiting
Wisconsin
      Pfizer Investigational Site, Madison,  Wisconsin,  53719,  United States; Recruiting
Australia
      Pfizer Investigational Site, Darlinghurst,  NSW 2010,  Australia; Recruiting
Australia, New South Wales
      Pfizer Investigational Site, Camperdown,  New South Wales,  2050,  Australia; Recruiting
Australia, Queensland
      Pfizer Investigational Site, Woolloongabba,  Queensland,  4102,  Australia; Recruiting
Australia, South Australia
      Pfizer Investigational Site, North Adelaide,  South Australia,  5006,  Australia; Recruiting
Australia, Victoria
      Pfizer Investigational Site, Clayton,  Victoria,  3168,  Australia; Recruiting
Australia, Western Australia
      Pfizer Investigational Site, Perth,  Western Australia,  6000,  Australia; Recruiting
Canada, Quebec
      Pfizer Investigational Site, Montreal,  Quebec,  H2W 1R7,  Canada; Recruiting
      Pfizer Investigational Site, Ste Foy,  Quebec,  G1V 4M6,  Canada; Recruiting
      Pfizer Investigational Site, Chicoutimi,  Quebec,  G7H 5H6,  Canada; Recruiting
      Pfizer Investigational Site, Montreal,  Quebec,  H1T 1C8,  Canada; Recruiting
Denmark
      Pfizer Investigational Site, Arhus C,  8000,  Denmark; Recruiting
      Pfizer Investigational Site, Aalborg,  9100,  Denmark; Recruiting
France
      Pfizer Investigational Site, Paris,  75651 Cedex 13,  France; Recruiting
      Pfizer Investigational Site, Dijon,  21000,  France; Recruiting
      Pfizer Investigational Site, Nantes cedex 01,  44093,  France; Recruiting
France, Lille
      Pfizer Investigational Site, Unknown,  Lille,  59037,  France; Recruiting
Iceland
      Pfizer Investigational Site, Kopavogur,  201,  Iceland; Recruiting
Norway
      Pfizer Investigational Site, Oslo,  0027,  Norway; Recruiting
      Pfizer Investigational Site, Oslo,  0407,  Norway; Recruiting
South Africa
      Pfizer Investigational Site, Westdene,  9301,  South Africa; Recruiting
      Pfizer Investigational Site, Cape Town,  7925,  South Africa; Recruiting
South Africa, Cape Town
      Pfizer Investigational Site, Parow,  Cape Town,  7500,  South Africa; Recruiting
South Africa, Western Cape
      Pfizer Investigational Site, Bellville,  Western Cape,  7531,  South Africa; Recruiting
Sweden
      Pfizer Investigational Site, Linköping,  581 85,  Sweden; Recruiting
      Pfizer Investigational Site, Goteborg,  413 45,  Sweden; Recruiting
      Pfizer Investigational Site, Stockholm,  141 86,  Sweden; Recruiting
      Pfizer Investigational Site, Malmö,  205 02,  Sweden; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A5091026
Last Updated:  August 24, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00134485
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30