| March 21, 2008 |
| November 17, 2009 |
| March 2008 |
| December 2009 (final data collection date for primary outcome measure) |
- Lipids (Triglycerides, LDL, HDL) [ Time Frame: Before and after 4 weeks of both fenofibrate and placebo ] [ Designated as safety issue: No ]
- CRP [ Time Frame: Before and after 4 weeks of both fenofibrate and placebo ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00644592 on ClinicalTrials.gov Archive Site |
| |
| |
| |
| LXRA Gene Polymorphisms and Response to Fenofibrate |
| LXRA Gene Polymorphisms and Response to Fenofibrate |
This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate. |
| |
| |
| Interventional |
| Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
| Healthy |
- Drug: Fenofibrate
- Drug: Placebo
|
| |
| |
| |
| Active, not recruiting |
| 60 |
| December 2009 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Triglycerides equal to or above 150mg/dL or Low HDL (below 44 mg/dl for men or below 54 mg/dl for women)
- Must be able to swallow tablets
Exclusion Criteria:
- Known Coronary Heart Disease, symptomatic carotid artery disease, abdominal aortic aneurysm, diabetes, or Framingham risk score above 20%
- Pregnancy, malignancy, liver dysfunction, renal dysfunction, active alcohol abuse, history of unexplained muscle pain
- Current treatment with lipid lowering therapy, estrogens, androgens, progestins, thiazide diuretics, beta-blockers, glucocorticoids (other than inhaled), antihistamines, or chronic anti-inflammatory drugs
- Current treatment with the following the interacting drugs: ursodeoxycholic acid, ursodiol, cholestyramine, red yeast rice, glyburide, glipizide, warfarin, or cyclosporine
|
| Both |
| 18 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00644592 |
| Issam Zineh, PharmD, University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics |
| 302-2007 |
| University of Florida |
| American College of Clinical Pharmacy |
| Principal Investigator: |
Issam Zineh, PharmD |
University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics |
|
|
| University of Florida |
| November 2009 |