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Study is to evaluate the effect of Nebivolol to treat high blood pressure compared to an already approved drug, Metoprolol ER with background treatment of Amlodipine.
Open-label, single center study consisting of a 2 to 4 week baseline washout phase, a 12-week Amlodipine background treatment phase followed by a 4-week Low Dose Nebivolol/Metoprolol Treatment phase and a 4-week High Dose Nebivolol/Metoprolol Treatment Phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Background treatment phase | No Intervention | A 12- week Amlodipine 10 mg background treatment phase | |
| Low Dose Treatment Phase-Nebivolol I | Active Comparator | 4-week low dose Nebivolol10 mg/Metoprolol 50 mg treatment phase |
|
| High dose treatment Phase-Nebivolol II | Active Comparator | 4-week High dose Nebivolol 20 mg/Metoprolol 100mg treatment phase |
|
| Baseline Washout Phase | Other | 2 to 4 week Baseline Washout Phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol I | Drug | Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from baseline in trough Diastolic Blood Pressure | Mean change by millimeters of mercury from baseline in trough Diastolic Blood Pressure | 4 and 8 weeks of treatment |
| Mean Change in Edema Measurement | Mean change in edema measurement by water immersion of treatment in millimeters of water | 4 and 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in trough Systolic blood pressure of treatment. | Change from baseline by millimeters of mercury in trough Systolic blood pressure of treatment. | 4 and 8 weeks of treatment |
| Percentage of subjects achieving Blood pressure goals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry A Punzi, MD | Punzi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Punzi Medical Center | Carrollton | Texas | 75006 | United States |
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12-week Amlodipine background treatment phase followed by a 4-week Low dose Nebivolol/Metoprolol treatment phase and a 4-week high dose Nebivolol/Metoprolol treatment phase
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|
| Nebivolol II | Drug | Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg |
|
|
| Baseline Washout Phase | Other | 2 to 4 week Baseline Washout Phase |
|
Percentage of subjects achieving Blood pressure goals of either Nebivolol compared to Metoprolol
| 4 and 8 weeks of treatment |