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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014306-33 | Registry Identifier | EUDRACT |
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The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-770767 (Treatment A) | Experimental |
| |
| BMS-770767 (Treatment B) | Experimental |
| |
| BMS-770767 (Treatment C) | Experimental |
| |
| BMS-770767 (Treatment D) | Experimental |
| |
| Placebo (Treatment E) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-770767 | Drug | Active, Oral, 15 mg, Daily, 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lowering of LDL-C | Within 28 days following dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Blood Level) of BMS-770767 | Within 28 days following dosing | |
| Pharmacodynamic effects of BMS-770767 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, non-esterified free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG) |
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Inclusion Criteria:
Exclusion Criteria
This list is not inclusive additional information is provided in the protocol
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harrell, Robert | Little Rock | Arkansas | 72201 | United States | ||
| Cetero Research - San Antonio |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000625006 | BMS-770767 |
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| BMS-770767 |
| Drug |
Active, Oral, 50 mg, Daily, 28 days |
|
| BMS-770767 | Drug | Active, Oral, 150 mg, Daily, 28 days |
|
| BMS-770767 | Drug | Active, Oral, 50 mg BID, Daily, 28 days |
|
| Placebo | Drug | Placebo, Oral, 0 mg, daily, 28 days |
|
| Within 28 days following dosing |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Local Institution | Blacktown | New South Wales | 2148 | Australia |
| Local Institution | Hornsby | New South Wales | 2077 | Australia |
| Local Institution | Caboolture | Queensland | 4510 | Australia |
| Local Institution | South Brisbane | Queensland | 4101 | Australia |
| Local Institution | Daw Park | South Australia | 5041 | Australia |
| Local Institution | Nedlands | Western Australia | 6004 | Australia |
| Local Institution | Bathurst | New Brunswick | E2A 4X7 | Canada |
| Local Institution | Brampton | Ontario | L6T 3J1 | Canada |
| Local Institution | Toronto | Ontario | M8V 3X8 | Canada |
| Local Institution | Charlottetown | Prince Edward Island | C1A 5Y9 | Canada |
| Local Institution | Mirabel | Quebec | J7J 2K8 | Canada |
| Local Institution | Montreal | Quebec | H3J 2V5 | Canada |