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The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides.
Hypothesis: Study subjects receiving fenofibrate 54mg will maintain similar triglyceride levels as patients on 160mg of fenofibrate.
The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides. Secondary objectives include evaluating effect of the dosage change on low-density lipoprotein (LDL), HDL, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine (SCr), and the potential cost savings associated with prescribing 54mg instead of 160mg. Electronic medical records will be used to identify subjects and gather data on demographics, comorbid conditions, and concomitant lipid lowering therapy. Subjects will be recruited for enrollment via telephone by the principal investigator (PI), co-principal investigators (Co-PIs), or provider referral after eligibility screening and approval from their primary care physician. Subjects must provide written informed consent and Health Insurance Privacy and Accountability Act (HIPAA) privacy rule authorization prior to participation in this study. Subjects will be randomized to either the intervention arm (conversion to 54mg of fenofibrate) or to the control arm (remain on 160mg of fenofibrate). Subjects in both study arms will have fasting lipid panels, ALT/AST, and SCr evaluated at baseline. All subjects will have repeat labs approximately 8 weeks after enrollment. All subjects will continue to receive standard care based on lipid values. The study period will begin approximately October 29, 2010 and run to June 30, 2011.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 'Fenofibrate 54mg' | Experimental | Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks. |
|
| Control 'Fenofibrate 160mg' | No Intervention | Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate 54mg | Drug | Subjects will receive fenofibrate 54mg daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Triglyceride Levels | Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Low-density Lipoprotein (LDL) | LDL levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks |
| High-density Lipoprotein,(HDL) | HDL levels will be assessed in study participants 6-10 weeks after entry into study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kendra Manigault, PharmD | Pharmacy Resident | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente of Georgia | Atlanta | Georgia | 30305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks. Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily. |
| FG001 | Control | Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks. Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Triglyceride Levels | Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study. | Posted | Mean | Standard Deviation | milligram/deciliter | 6-10 weeks |
|
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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 | Intervention | Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks. Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kendra Manigault, PharmD, BCPS, BCACP, CDE | Mercer University/ Kaiser Permanente | 678-547-6216 | manigault_kr@mercer.edu |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| 6-10 weeks |
| Alanine Aminotransferase(ALT) | ALT levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks |
| Aspartate Aminotransferase (AST) | AST levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks |
| Serum Creatinine(SCr) | SCr levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks |
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Low-density Lipoprotein (LDL) | LDL levels will be assessed in study participants 6-10 weeks after entry into study. | Posted | Mean | Standard Deviation | milligram/deciliter | 6-10 weeks |
|
|
|
| Secondary | High-density Lipoprotein,(HDL) | HDL levels will be assessed in study participants 6-10 weeks after entry into study. | Posted | Mean | Standard Deviation | milligram/deciliter | 6-10 weeks |
|
|
|
| Secondary | Alanine Aminotransferase(ALT) | ALT levels will be assessed in study participants 6-10 weeks after entry into study. | Posted | Mean | Standard Deviation | international units/liter | 6-10 weeks |
|
|
|
| Secondary | Aspartate Aminotransferase (AST) | AST levels will be assessed in study participants 6-10 weeks after entry into study. | Posted | Mean | Standard Deviation | international units/liter | 6-10 weeks |
|
|
|
| Secondary | Serum Creatinine(SCr) | SCr levels will be assessed in study participants 6-10 weeks after entry into study. | Posted | Mean | Standard Deviation | milligram/deciliter | 6-10 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Control | Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks). | 0 | 29 | 0 | 29 |
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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 |