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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
40
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg
2 to 4 week Baseline Washout Phase
Punzi Medical Center
Carrollton, Texas, United States
Mean Change from baseline in trough Diastolic Blood Pressure
Mean change by millimeters of mercury from baseline in trough Diastolic Blood Pressure
Time frame: 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
Time frame: 4 and 8 weeks of treatment
Change from baseline in trough Systolic blood pressure of treatment.
Change from baseline by millimeters of mercury in trough Systolic blood pressure of treatment.
Time frame: 4 and 8 weeks of treatment
Percentage of subjects achieving Blood pressure goals
Percentage of subjects achieving Blood pressure goals of either Nebivolol compared to Metoprolol
Time frame: 4 and 8 weeks of treatment
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