Hypertension
Conditions
Keywords
Nebivolol, Bystolic TM, Hypertension, Stage 2 Hypertension
Brief summary
The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.
Interventions
DRUGNebivolol
5 mg, titrated to 20 mg, once daily oral administration
DRUGPlacebo
5 mg or 20 mg once daily, 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 64 Years
Healthy volunteers
No
Inclusion criteria
* male of female, 18 to 64 years of age at screening * mean seated heart rate at least 60 bpm * diagnosed systolic stage 2 hypertension * unremarkable physical exam findings
Exclusion criteria
* high risk due to secondary hypertension or former stage 3 hypertension by JNC6 * concurrent conditions (reno, cardiovascular, obesity, thyroid, etc) * currently taking medication that cannot be stopped during the course of the study * participating other clinical trials * member of the study center personnel * documented drug abuse * contra indication to beta blocker * abnormal lab finding * poor compliance * other conditions judged by investigator that is not suitable for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6) | Office blood pressure measured at trough by automatic oscillometric device. |
| Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | Change from Baseline (Week 0) to Visit 4 (Week 6) | Office blood pressure measured at trough by automatic oscillometric device. |
Countries
United States
Participant flow
Recruitment details
Recruitment occured from March 2010 through October 2010 at 36 US sites.
Pre-assignment details
A 4 week single-blind placebo washout phase was required for patients on anti-hypertensives at screening.
Participants by arm
| Arm | Count |
|---|---|
| Nebivolol 5 mg, titrated to 20 mg, once daily oral administration | 290 |
| Placebo Dose-matched placebo, once daily oral administration | 142 |
| Total | 432 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Did not meet InclusionExclusion criteria | 4 | 2 |
| Overall Study | Lack of Efficacy | 2 | 11 |
| Overall Study | Lost to Follow-up | 7 | 6 |
| Overall Study | Other Reason | 1 | 1 |
| Overall Study | Protocol Violation | 6 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Placebo | Nebivolol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 142 Participants | 290 Participants | 432 Participants |
| Age Continuous | 49.7 years STANDARD_DEVIATION 9 | 51.1 years STANDARD_DEVIATION 8.1 | 50.6 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment United States | 142 participants | 290 participants | 432 participants |
| Sex: Female, Male Female | 61 Participants | 141 Participants | 202 Participants |
| Sex: Female, Male Male | 81 Participants | 149 Participants | 230 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 290 | 0 / 142 |
| serious Total, serious adverse events | 1 / 290 | 3 / 142 |
Outcome results
Primary
Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
Office blood pressure measured at trough by automatic oscillometric device.
Time frame: Change from Baseline (Week 0) to Visit 4 (Week 6)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | -12.3 mm Hg | Standard Deviation 9.8 |
| Placebo | Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | -5.7 mm Hg | Standard Deviation 11.4 |
Primary
Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
Office blood pressure measured at trough by automatic oscillometric device.
Time frame: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | -18.2 mm Hg | Standard Deviation 16.7 |
| Placebo | Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | -12.3 mm Hg | Standard Deviation 17.7 |