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supply issues with the formulation of fenofibrate that was used.
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| Name | Class |
|---|---|
| American College of Clinical Pharmacy | OTHER |
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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.
This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-Fenofibrate then Placebo | Active Comparator | 4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo |
|
| 2 Placebo then Fenofibrate | Active Comparator | 4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate capsule daily for 4 weeks | Drug | Placebo capsule daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Log(ENA-Period 2 End/ENA Period 1 End) | Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects. Natural logs used | week 12 to week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Issam Zineh, PharmD | University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida College of Pharmacy, Center for Pharmacogenomics | Gainesville | Florida | 32610 | United States |
Patients were screened for eligibility.
UF Clinical Research Center. Started March 2008, completed August 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-Fenofibrate Then Placebo | 4 weeks of drug at 160 mg orally per day |
| FG001 | 2 Placebo Then Fenofibrate | 4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-Fenofibrate Then Placebo | 4 weeks of drug at 160 mg orally per day |
| BG001 | 2 Placebo Then Fenofibrate | 4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Log(ENA-Period 2 End/ENA Period 1 End) | Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects. Natural logs used | Intent was to enroll 30 but drug was withdrawn by provider, with only 11 completing both experimental periods | Posted | Mean | Standard Deviation | Log of Ratio | week 12 to week 4 |
|
4 Weeks on Treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1-Fenofibrate | 4 weeks of drug at 160 mg orally per day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | Abdominal Complaints |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reginald F. Frye, PhD, Associate Professor | University of Florida | 3522735453 | fryerf@ufl.edu |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Fenofibrate | Drug | 160 mg/day orally for 4 weeks |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | 2 Placebo | 4 weeks of placebo. | 0 | 11 | 2 | 11 |
|
| Rash | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment | Skin rash |
|
| Nausea/Vomiting | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |