To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients with genetically known disorder of extremely high cholesterol

Condition	Intervention	Phase
Hypercholesterolemia, Familial	Drug: Torcetrapib/atorvastatin	Phase III

Further Study Details: 

Primary Outcomes: Change in LDL-C and HDL-C
Secondary Outcomes: Other lipid variables
Expected Total Enrollment:  30

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

Criteria

Inclusion Criteria:

• Diagnosis of Homozygous Familial Hypercholesterolemia

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  NCT00134511

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

Massachusetts
      Pfizer Investigational Site, Boston,  Massachusetts,  02114,  United States; Recruiting
Canada, Quebec
      Pfizer Investigational Site, Chicoutimi,  Quebec,  G7H 5H6,  Canada; Recruiting
      Pfizer Investigational Site, Ste Foy,  Quebec,  G1V 4M6,  Canada; Recruiting
South Africa
      Pfizer Investigational Site, Westdene,  9301,  South Africa; Recruiting
      Pfizer Investigational Site, Cape Town,  7925,  South Africa; Recruiting
South Africa, Johannesburg
      Pfizer Investigational Site, PARKTOWN,  Johannesburg,  2193,  South Africa; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A5091027
Last Updated:  August 24, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00134511
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30