Hypertension
Conditions
Keywords
Hypertension, Blood pressure, Nebivolol, Bystolic (TM), Metoprolol ER (TM)
Brief summary
The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.
Interventions
DRUGNebivolol
nebivolol 10mg, 20mg, 40mg daily dosage, oral administration
DRUGMetoprolol ER (TM)
Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, ambulatory outpatients 18-79 years old at screening * Minimum 2-year history of Stage I/II hypertension * Qualifying blood pressure criteria for study entry and for randomization * Willing to adhere to the dietary compliance and undergo protocol procedures * Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days
Exclusion criteria
* Have any form of secondary hypertension * Have clinically significant respiratory or cardiovascular disease * Presence/history of coronary artery disease or peripheral vascular disease * Have diabetes mellitus, Type I or II * Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR). | Before treatment and after 10 weeks | Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10). |
Countries
United States
Participant flow
Recruitment details
The recruitment period was from November 2007 to May 2009 at one US location.
Pre-assignment details
All patients went through a 4-5 week, single blind, placebo washout phase before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Nebivolol A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase | 6 |
| Metoprolol ER (TM) A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
Baseline characteristics
| Characteristic | Metoprolol ER (TM) | Nebivolol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 5 Participants |
| Age Continuous | 67.3 years STANDARD_DEVIATION 11.6 | 59.5 years STANDARD_DEVIATION 5.8 | 63.4 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).
Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).
Time frame: Before treatment and after 10 weeks
Population: Due to the small sample size, no efficacy conclusion could be made. 0 measured value primary outcome =Not applicable.