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| ID | Type | Description | Link |
|---|---|---|---|
| TREAC Cholesterol Study |
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| Name | Class |
|---|---|
| American Society of Health-System Pharmacists Research and Education Foundation | OTHER |
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To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.
: Patients with hyperlipidemia who sign consent and who are currently at maximum tolerated dose of a statin and are not meeting NCEP ATPIII treatment goals for LDL cholesterol are enrolled in 12-week open label, prospective trial. Patients are randomized into one of three groups to receive ezetimibe, niacin, or colestipol in addition to current statin therapy. Patients are titrated as tolerated to therapeutic doses of study medications (ezetimibe 10mg/day, niacin 1500mg/day, and colestipol 20gm/day). At baseline, informed consent; a laboratory admission profile (Chem20); weight; height; blood pressure; concomitant medications; cholesterol medication history; and grapefruit juice consumption data are gathered. At weeks 6 and 12, patients have their cholesterol panels and liver function tests assessed. Patients are also interviewed regarding side effects (including rhabdomyolysis), tolerance, changes in concomitant medications, and grapefruit juice consumption, along with weight and blood pressure measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin with Niacin | Active Comparator | Niacin dose range of 500-1500mg (average 888mg) |
|
| Statin with Colestipol | Active Comparator | Colestipol dose range 5-15gm (average 9.5gm) |
|
| Statin with Ezitimibe | Active Comparator | Ezitimibe 10mg (average 10mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niacin | Drug |
| ||
| Colestipol |
| Measure | Description | Time Frame |
|---|---|---|
| LDL Goal Attainment | Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| LFT Elevation | 12 weeks | |
| Incidents of Rhabdomyolysis | 12 weeks | |
| Change in HDL From Baseline to 12 Weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raela B Williford, PharmD | Tuscaloosa Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscaloosa Research & Education Advancement Corporation | Tuscaloosa | Alabama | 35404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15683599 | Background | Ansell BJ. Rationale for combination therapy with statin drugs in the treatment of dyslipidemia. Curr Atheroscler Rep. 2005 Feb;7(1):29-33. doi: 10.1007/s11883-005-0072-7. |
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Patients had to be on max tolerated dose of a statin and need additional LDL lowering.
Patients were recruited from 2005-2007 from primary care medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Niacin | Niacin added to max tolerated dose of statin |
| FG001 | Colestipol | Colestipol added to max dose statin |
| FG002 | Ezetimibe | Ezetimibe added to max tolerated dose statin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
100% male, age 50 years or greater
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| ID | Title | Description |
|---|---|---|
| BG000 | Niacin | Niacin added to max tolerated dose of statin |
| BG001 | Colestipol | Colestipol added to max dose statin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | LDL Goal Attainment | Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines. | intention to treat | Posted | Number | participants | 12 weeks |
|
12 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 | Niacin | Niacin added to max tolerated dose of statin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated LFTs | Hepatobiliary disorders | Systematic Assessment | 1 participant in the ezetimibe group had LFTs >3 x upper limit of normal. All other elevated LFTs were not 3 x ULN. |
Open label.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raela Williford, PharmD | TuscaloosaREAC | (205) 554-2000 | 2433 | Raela.Williford@va.gov |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| D003084 | Colestipol |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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|
| Ezetimibe | Drug |
|
|
| baseline and 12 weeks |
| BG002 |
| Ezetimibe |
Ezetimibe added to max tolerated dose statin |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | LFT Elevation | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Incidents of Rhabdomyolysis | Posted | Dec 2007 | Number | participants | 12 weeks |
|
|
|
| Secondary | Change in HDL From Baseline to 12 Weeks. | Change in HDL | Posted | Dec 2007 | Mean | Standard Deviation | mg/dl | baseline and 12 weeks |
|
|
|
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Colestipol | Colestipol added to max dose statin | 0 | 10 | 3 | 10 |
| EG002 | Ezetimibe | Ezetimibe added to max tolerated dose statin | 0 | 10 | 3 | 10 |
|
| Indestion and belching | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Loose Stools | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Edema | Vascular disorders | Non-systematic Assessment |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D001384 | Azetidines |
| D001385 | Azetines |
|