Hypertension
Conditions
Keywords
Hypertension, Beta-blockers, Ambulatory blood pressure, Basal metabolic rate, Quality of life
Brief summary
The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour ambulatory blood pressure characteristics and basal metabolic rates in patients with hypertension.
Interventions
DRUGMetoprolol
Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks
DRUGNebivolol
5 - 20 mg daily, at a stable dose for 4 to 5 weeks
Sponsors
University of Mississippi Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old or older * currently be treated at a University of MS Medical Center Internal Medicine Clinics * currently taking metoprolol succinate for hypertension * have their hypertension controlled (\<140/90).
Exclusion criteria
* uncontrolled hypertension * severe renal or moderate hepatic impairment * currently taking CYP 2D6 inducers/inhibitors * recent stroke (less than 6 months) * recent myocardial infarction (less than 6 months) * congestive heart failure * diagnosed obstructive sleep apnea * atrial fibrillation * arm circumference \>50 cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. | 4 weeks (pre- and post-treatment) |
Countries
United States
Participant flow
Recruitment details
From 11/2008-4/2009, 472 patient were prescribed metoprolol succinate. During screening, metoprolol succinate was discontinued in 87 patients and 177 were excluded (obstacles to visits, competency issues). A national shortage of metoprolol succinate caused discontinuation in mant patients. One patient was enrolled and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Metoprolol to Nebivolol Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.
Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Metoprolol to Nebivolol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.
Time frame: 4 weeks (pre- and post-treatment)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Metoprolol to Nebivolol | Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. | SBP ABPM on metoprolol | 122 mm HG |
| Metoprolol to Nebivolol | Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. | DBP ABPM on metoprolol | 72 mm HG |
| Metoprolol to Nebivolol | Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. | SBP ABPM on nebivolol | 122 mm HG |
| Metoprolol to Nebivolol | Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. | DBP ABPM on nebivolol | 71 mm HG |