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Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.
Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/< 1 drink per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | 2.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8 |
|
| 1 | Active Comparator | Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | atorvastatin 20 mg tablets, daily dosing, for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in LDL-C After 8 Weeks of Therapy | Baseline and 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Belknap, MD | Medical Monitor at Radiant Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linda Murray, DO - Radiant Research | Pinellas Park | Florida | 33781 | United States | ||
| Sheila Rodstein, MD |
5-week run-in period during which patients were to follow a low-fat diet and washout from previous lipid lowering therapies.
This study was performed from 12 May 2008 to 29 Aug 2008. A total of 5 medical clinics participated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin 20 mg | Oral atorvastatin 20 mg for 8 weeks |
| FG001 | Atorvastatin 20 mg + Lomitapide | Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AEGR-733 | Drug | 2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks |
|
| Edina |
| Minnesota |
| 55435 |
| United States |
| Dennis McCluskey, MD - Radiant Research | Mogadore | Ohio | 44260 | United States |
| Michele Reynolds, MD | Dallas | Texas | 75231 | United States |
| William Jennings, MD - Radiant Research | San Antonio | Texas | 78229 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin 20 mg | Oral atorvastatin 20 mg for 8 weeks |
| BG001 | Atorvastatin 20 mg + Lomitapide | Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Percent Change in LDL-C After 8 Weeks of Therapy | Posted | Mean | Standard Deviation | Percent Change | Baseline and 8 weeks of treatment |
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| ||||||||||||||||||||||||||||||
| Secondary | Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. | Posted | Mean | Standard Deviation | Percent | Baseline and 4 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 | Atorvastatin 20 mg | Oral atorvastatin 20 mg for 8 weeks | 0 | 23 | 16 | 23 | ||
| EG001 | Atorvastatin 20 mg + Lomitapide | Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg | 0 | 21 | 16 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Flatuence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dermal cyst | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
Information is unavailable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Aegerion Pharmaceuticals | 617-500-7867 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| C473731 | BMS201038 |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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