Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol.
Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack, specifically for patients who have heart disease plus major risk factors. Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations for cholesterol in a large number of subjects. Thus, the development of new medications that can provide additional cholesterol lowering may be beneficial.
This study tests the effectiveness of different doses of the study drug, AEGR-733 alone and in combination with the approved cholesterol lowering drug, atorvastatin (Lipitor), on cholesterol. Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication (3 capsules daily) for 8 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Experimental |
| |
| 6 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 20 mg | Drug |
| ||
| AEGR-733 5 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in LDL-C at 8 Weeks | Atfer 8 weeks on study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline of Other Lipids | After 8 weeks of study drug |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affiliated Research Center | Huntsville | Alabama | 35801 | United States | ||
| Jacksonville Center for Clinical research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17215532 | Background | Cuchel M, Bloedon LT, Szapary PO, Kolansky DM, Wolfe ML, Sarkis A, Millar JS, Ikewaki K, Siegelman ES, Gregg RE, Rader DJ. Inhibition of microsomal triglyceride transfer protein in familial hypercholesterolemia. N Engl J Med. 2007 Jan 11;356(2):148-56. doi: 10.1056/NEJMoa061189. |
Not provided
Not provided
Subjects who were previously on a lipid lowering therapy underwent a 5-week washout period. All subjects were on a low-fat diet (<30% calories from fat) starting 5 weeks prior to study drug treatment and continuing for the duration of the study.
The study was performed from 05 November 2007 to 04 August 2008 at 17 medical clinics within the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo capsule taken orally once daily |
| FG001 | Atorvastatin 20 mg | Atorvastatin 20 mg taken orally once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| AEGR-733 10 mg | Drug |
|
| Placebo | Drug |
|
| AEGR-733 5 mg + atorvastatin 20 mg | Drug |
|
| AEGR-733 10 mg + atorvastatin 20 mg | Drug |
|
| Jacksonville |
| Florida |
| 32205 |
| United States |
| Jacksonville Center For Clinical Research | Jacksonville | Florida | 32216 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | United States |
| Radiant Research | Chicago | Illinois | 60610 | United States |
| Medsphere Medical Research Center | Evansville | Indiana | 47714 | United States |
| Midwest Institute for Clinical Research | Indianapolis | Indiana | 46260 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| Health Trends Research | Baltimore | Maryland | 21209 | United States |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | United States |
| Sterling Research Group | Cincinnati | Ohio | 45246 | United States |
| Coastal Carolina Research Center | Goose Creek | South Carolina | 29445 | United States |
| Dallas Diabetes and Endocrine Center | Dallas | Texas | 75230 | United States |
| Diabetes and Glandular Disease Research | Dallas | Texas | 78229 | United States |
| Hampton Roads Center for Clinical Research | Norfolk | Virginia | 23502 | United States |
| National Clinical Research | Richmond | Virginia | 23294 | United States |
| FG002 | AEGR-733 5 mg | AEGR-733 5 mg taken orally once daily |
| FG003 | AEGR-733 10 mg | AEGR-733 10 mg taken orally once daily |
| FG004 | AEGR-733 5 mg + Atorvastatin 20 mg | One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily |
| FG005 | AEGR-733 10 mg + Atorvastatin 20 mg | One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo capsule taken orally once daily |
| BG001 | Atorvastatin 20 mg | Atorvastatin 20 mg taken orally once daily |
| BG002 | AEGR-733 5 mg | AEGR-733 5 mg taken orally once daily |
| BG003 | AEGR-733 10 mg | AEGR-733 10 mg taken orally once daily |
| BG004 | AEGR-733 5 mg + Atorvastatin 20 mg | One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily |
| BG005 | AEGR-733 10 mg + Atorvastatin 20 mg | One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily |
| BG006 | 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 From Baseline in LDL-C at 8 Weeks | Intent To Treat | Posted | Mean | Standard Deviation | Percent Change | Atfer 8 weeks on study drug |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline of Other Lipids | Intent To Treat | Posted | Mean | Standard Deviation | Percent | After 8 weeks of study drug |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo capsule taken orally once daily | 0 | 27 | 17 | 27 | ||
| EG001 | Atorvastatin 20 mg | Atorvastatin 20 mg taken orally once daily | 0 | 26 | 15 | 26 | ||
| EG002 | AEGR-733 5 mg | AEGR-733 5 mg taken orally once daily | 1 | 26 | 23 | 26 | ||
| EG003 | AEGR-733 10 mg | AEGR-733 10 mg taken orally once daily | 1 | 26 | 23 | 26 | ||
| EG004 | AEGR-733 5 mg + Atorvastatin 20 mg | One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily | 0 | 26 | 21 | 26 | ||
| EG005 | AEGR-733 10 mg + Atorvastatin 20 mg | One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily | 0 | 26 | 24 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Flatulence | Gastrointestinal disorders |
| |||
| Abdominal Distension | Gastrointestinal disorders |
| |||
| Nasopharyngitis | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Abdominal Pain Upper | Gastrointestinal disorders |
| |||
| Aspartate aminotransferase increased | Investigations |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Muscle spasms | Musculoskeletal and connective tissue disorders |
| |||
| Abdominal Pain | Gastrointestinal disorders |
| |||
| Decreased Appetite | Metabolism and nutrition disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Urinary Tract Infection | Infections and infestations |
| |||
| Headache | Nervous system disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Gastroenteritis Viral | Infections and infestations |
| |||
| Chest Pain | General disorders |
| |||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Hepatice Enzyme Increased | Investigations |
| |||
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders |
| |||
| Eructation | Gastrointestinal disorders |
| |||
| Asthenia | Gastrointestinal disorders |
| |||
| Upper Respiratory Tract Infection | Infections and infestations |
| |||
| Dry Skin | Skin and subcutaneous tissue disorders |
| |||
| Blood Urine | Investigations |
| |||
| Gastric Dilatation | Gastrointestinal disorders |
| |||
| Blood Potassium Increased | Investigations |
|
Study AEGR-733-003, initiated in May 2007, was halted, and restarted under an amended Protocol in November 2007.
Information is unavailable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Aegerion Pharmaceuticals | 617-500-7867 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily |
|
|