To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.

Condition	Intervention	Phase
Hypertriglyceridemia Hyperlipoproteinemia Type IV	Drug: torcetrapib/atorvastatin  Drug: atorvastatin	Phase III

Further Study Details: 

Primary Outcomes: Change in HDL-C and non-HDL-C levels
Secondary Outcomes: Changes in levels of other lipid and biomarkers.
Expected Total Enrollment:  160

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

Criteria

Inclusion Criteria:

• Diagnosis of Fredrickson Type IV Hypertriglyceridemia

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  NCT00134498

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

California
      Pfizer Investigational Site, Anaheim,  California,  92804,  United States; Recruiting
      Pfizer Investigational Site, Los Angeles,  California,  90057,  United States; Recruiting
      Pfizer Investigational Site, Orange,  California,  92868,  United States; Recruiting
      Pfizer Investigational Site, Pacific Palisades,  California,  90272,  United States; Recruiting
      Pfizer Investigational Site, Studio City,  California,  91604,  United States; Recruiting
      Pfizer Investigational Site, Huntington Beach,  California,  92648,  United States; Recruiting
      Pfizer Investigational Site, Tustin,  California,  92780,  United States; Recruiting
Connecticut
      Pfizer Investigational Site, Farmington,  Connecticut,  06030,  United States; Recruiting
District of Columbia
      Pfizer Investigational Site, Washington,  District of Columbia,  20037,  United States; Recruiting
Florida
      Pfizer Investigational Site, West Palm Beach,  Florida,  33401,  United States; Recruiting
      Pfizer Investigational Site, Longwood,  Florida,  32779,  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
Kansas
      Pfizer Investigational Site, Overland Park,  Kansas,  66215,  United States; Recruiting
Louisiana
      Pfizer Investigational Site, Baton Rouge,  Louisiana,  70808,  United States; Recruiting
      Pfizer Investigational Site, Baton Rouge,  Louisiana,  70816,  United States; Recruiting
Maine
      Pfizer Investigational Site, Scarborough,  Maine,  04074,  United States; Recruiting
Maryland
      Pfizer Investigational Site, Bethesda,  Maryland,  20817,  United States; Recruiting
Michigan
      Pfizer Investigational Site, Portage,  Michigan,  49002,  United States; Recruiting
      Pfizer Investigational Site, Portage,  Michigan,  49024,  United States; Recruiting
      Pfizer Investigational Site, Richland,  Michigan,  49083,  United States; Recruiting
      Pfizer Investigational Site, Ann Arbor,  Michigan,  48106,  United States; Recruiting
      Pfizer Investigational Site, Canton,  Michigan,  48187,  United States; Recruiting
Minnesota
      Pfizer Investigational Site, St. Cloud,  Minnesota,  56303,  United States; Recruiting
      Pfizer Investigational Site, St. Cloud,  Minnesota,  56303-1901,  United States; Recruiting
Mississippi
      Pfizer Investigational Site, Olive Branch,  Mississippi,  38654,  United States; Recruiting
Missouri
      Pfizer Investigational Site, Jefferson City,  Missouri,  65109,  United States; Recruiting
Nevada
      Pfizer Investigational Site, Las Vegas,  Nevada,  89128,  United States; Recruiting
New York
      Pfizer Investigational Site, Syracuse,  New York,  13210,  United States; Recruiting
      Pfizer Investigational Site, West Seneca,  New York,  14224,  United States; Recruiting
North Carolina
      Pfizer Investigational Site, Statesville,  North Carolina,  28677,  United States; Recruiting
Pennsylvania
      Pfizer Investigational Site, Sellersville,  Pennsylvania,  18960,  United States; Recruiting
Rhode Island
      Pfizer Investigational Site, Warwick,  Rhode Island,  02886,  United States; Recruiting
Virginia
      Pfizer Investigational Site, Richmond,  Virginia,  23294,  United States; Recruiting
Wisconsin
      Pfizer Investigational Site, Madison,  Wisconsin,  53719,  United States; Recruiting
Canada, Nova Scotia
      Pfizer Investigational Site, Halifax,  Nova Scotia,  B3H 1V7,  Canada; Recruiting
Canada, Ontario
      Pfizer Investigational Site, London,  Ontario,  N6A 5K8,  Canada; 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

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A5091025
Last Updated:  August 24, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00134498
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30