Dyslipidemia, Hyperlipidemia
Conditions
Brief summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of combination cholesterol medications to see how the different treatments compare to one another.
Detailed description
For additional information please call: 1-800-718-1021
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Specific LDL-C levels based on CHD risk after a six-week washout period.
Exclusion criteria
* Women who are pregnant or lactating, or planning to become pregnant. * Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors. * Subjects requiring systemic steroids * Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in other lipid parameters and other biomarkers. | — |
Countries
United States
Outcome results
None listed