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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001946-17 | EudraCT Number |
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The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-852927 (0.25 mg) | Experimental |
| |
| Arm 2: BMS-852927 (1.0 mg) | Experimental |
| |
| Arm 3: BMS-852927 (2.5 mg) | Experimental |
| |
| Arm 4: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-852927 | Drug | Capsules, Oral, 0.25 mg, Once daily, 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy | Up to 56 days of study participation | |
| Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy | Up to 30 days post discontinuation of dosing or last participation in the study for serious adverse events collection | |
| Number and percent of subjects with potentially clinically significant changes in ECG parameter | Electrocardiogram (ECG) parameters defined as:
| Upto 56 days |
| Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured) | LDL-c (measured) defined as:
| Upto 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data | Days 7, 14, 21 and 28 | |
| Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Brampton | Ontario | L6T 0G1 | Canada | ||
| Local Institution |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| BMS-852927 |
| Drug |
Capsules, Oral, 1.0 mg, Once daily, 28 days |
|
| BMS-852927 | Drug | Capsules, Oral, 2.5 mg, Once daily, 28 days |
|
| Placebo | Drug | Capsules, Oral, 0 mg, Once daily, 28 days |
|
| Days 1 and 28 |
| Toronto |
| Ontario |
| M4G 3E8 |
| Canada |
| Local Institution | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Local Institution | Québec | Quebec | G1N 4V3 | Canada |
| Local Institution | Québec | Quebec | G3K 2P8 | Canada |
| Local Institution | Victoriaville | Quebec | G6P 6P6 | Canada |
| Local Institution | Berlin | 10117 | Germany |
| Local Institution | Neuss | 41460 | Germany |
| D009750 |
| Nutritional and Metabolic Diseases |