Hypercholesterolemia, Familial
Conditions
Brief summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients with genetically known disorder of extremely high cholesterol
Detailed description
For additional information please call: 1-800-718-1021
Interventions
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in LDL-C and HDL-C | — |
Secondary
| Measure | Time frame |
|---|---|
| Other lipid variables | — |
Countries
Canada, South Africa, United States
Outcome results
None listed