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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000509-54 | EudraCT Number |
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The purpose of this study is to determine whether BMS-823778 is safe and effective in the treatment of hypertension in overweight and obese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-823778 (2mg) | Experimental |
| |
| Arm2: BMS-823778 (6mg) | Experimental |
| |
| Arm 3: BMS-823778 (15mg) | Experimental |
| |
| Arm4: Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-823778 | Drug | Capsules, Oral, 2 mg, Once daily, 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The dose-dependent trend among doses of BMS-823778 and placebo by assessing the change from baseline in 24-hour ambulatory diastolic blood pressure following 12 weeks of double-blind treatment | At Day -7 (baseline) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend) | At Day -7 (baseline) and Week 12 | |
| Change in 24-hour ambulatory diastolic blood pressure (DBP) | At Day -7 (baseline) and Week 12 |
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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 |
|---|---|---|---|---|---|---|
| Nea Baptist Clinic | Jonesboro | Arkansas | 72401 | United States | ||
| Local Institution |
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| BMS-823778 |
| Drug |
Capsules, Oral, 6 mg, Once daily, 12 weeks |
|
| BMS-823778 | Drug | Capsules, Oral, 15 mg, Once daily, 12 weeks |
|
| Placebo matching with BMS-823778 | Drug | Capsules, Oral, 0 mg, Once daily, 12 weeks |
|
| Change in 24-hour ambulatory SBP | At Day -7 (baseline) and Week 12 |
| Change in ambulatory daytime and nighttime DBP | At Day -7 (baseline) and Week 12 |
| Change in ambulatory daytime and nighttime SBP | At Day -7 (baseline) and Week 12 |
| Change in seated DBP | At Day -7 (baseline) and Week 12 |
| Change in seated SBP | At Day -7 (baseline) and Week 12 |
| Los Angeles |
| California |
| 90057 |
| United States |
| Desert Medical Group Inc. | Palm Springs | California | 92262 | United States |
| Local Institution | Coral Gables | Florida | 33134 | United States |
| Local Institution | Atlanta | Georgia | 30303 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808-4124 | United States |
| Local Institution | New Orleans | Louisiana | 70115 | United States |
| Anderson And Collins Clinical Research, Inc. | Edison | New Jersey | 08817 | United States |
| Premier Research | Trenton | New Jersey | 08611 | United States |
| Syracuse Preventive Cardiology | Syracuse | New York | 13202-3108 | United States |
| Metrolina Internal Medicine | Charlotte | North Carolina | 28204 | United States |
| Pharmquest, Llc | Greensboro | North Carolina | 27408 | United States |
| Pmg Research Of Salisbury | Salisbury | North Carolina | 28144 | United States |
| Local Institution | Shelby | North Carolina | 28150 | United States |
| Local Institution | Shelby | North Carolina | 28152 | United States |
| Local Institution | Winston-Salem | North Carolina | 27103 | United States |
| Sterling Research Grp, Ltd. | Cincinnati | Ohio | 45246 | United States |
| Local Institution | Greenville | South Carolina | 29615 | United States |
| Local Institution | Layton | Utah | 84041 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| National Clinical Research - Norfolk, Inc. | Norfolk | Virginia | 23502 | United States |
| National Clinical Research - Richmond, Inc. | Richmond | Virginia | 23294 | United States |
| Local Institution | Barranquilla | Colombia |
| Local Institution | Bucaramanga | Colombia |
| Local Institution | Cartagena | Colombia |
| Local Institution | Manizales | Colombia |
| Local Institution | Medellín | Colombia |
| Local Institution | Balatonfüred | H-8230 | Hungary |
| Local Institution | Budapest | 1125 | Hungary |
| Local Institution | Budapest | 1133 | Hungary |
| Local Institution | Budapest | 1134 | Hungary |
| Local Institution | Debrecen | 4026 | Hungary |
| Local Institution | Ponce | 00717 | Puerto Rico |
| Local Institution | Ödeshög | 599 31 | Sweden |
| Local Institution | Stockholm | 141 86 | Sweden |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000624964 | BMS-823778 |
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