Hypertension
Conditions
Keywords
nebivolol, Bystolic®, Hypertension, blood pressure, withdrawal
Brief summary
This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.
Interventions
DRUGNebivolol
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
DRUGPlacebo
Matching placebo tablets, 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 and female outpatients 18 to 79 years of age * Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen * meet criteria for stage I or II hypertension * currently not treated, or being treated with no more than two anti-hypertensive medications
Exclusion criteria
* type 1 or type 2 diabetes * secondary hypertension * evidence of other concurrent disease or conditions that might interfere with the conduct of the study * treatment with any investigational study drug within 30 days of Screening (Visit 1) * have a history of hypersensitivity to nebivolol or other β-blockers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough Sitting Diastolic Blood Pressure | From baseline, week 0 (Visit 9) to week 4 (Visit 12) | Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trough Sitting Systolic Blood Pressure | From baseline, week 0 (Visit 9) to week 4 (Visit 12) | Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough. |
Countries
United States
Participant flow
Recruitment details
The recruitment period was five months, from November 2008 through March 2009.
Pre-assignment details
Patients went through a 4-5 week, single blind, placebo run-in/washout phase, followed by a 12 week single-blind active treatment phase with nebivolol before randomization
Participants by arm
| Arm | Count |
|---|---|
| Nebivolol Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration | 102 |
| Placebo Matching placebo tablets, oral administration | 105 |
| Total | 207 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 |
| Overall Study | Inclusion/Exclusion not meet | 0 | 0 |
| Overall Study | IVRS Programing Error | 0 | 0 |
| Overall Study | Lack of compliance | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Physician Decision | 0 | 0 |
| Overall Study | Precedure Refused | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Nebivolol | Total |
|---|---|---|---|
| Age Categorical <18 years | 0 participants | 0 participants | 0 participants |
| Age Categorical >=65 years | 14 participants | 16 participants | 30 participants |
| Age Categorical Ages 18 to 64 years | 91 participants | 86 participants | 177 participants |
| Age Continuous | 52.9 years STANDARD_DEVIATION 10.2 | 52.6 years STANDARD_DEVIATION 11.2 | 52.8 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment United States | 105 participants | 102 participants | 207 participants |
| Sex: Female, Male Female | 43 Participants | 43 Participants | 86 Participants |
| Sex: Female, Male Male | 62 Participants | 59 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 269 | 0 / 102 | 0 / 105 |
| serious Total, serious adverse events | 2 / 269 | 0 / 102 | 0 / 105 |
Outcome results
Primary
Trough Sitting Diastolic Blood Pressure
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.
Time frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nebivolol | Trough Sitting Diastolic Blood Pressure | Baseline | 81.3 mm HG | Standard Deviation 7.2 |
| Nebivolol | Trough Sitting Diastolic Blood Pressure | Change from baseline | 1.8 mm HG | Standard Deviation 7.3 |
| Placebo | Trough Sitting Diastolic Blood Pressure | Baseline | 81.1 mm HG | Standard Deviation 7 |
| Placebo | Trough Sitting Diastolic Blood Pressure | Change from baseline | 7.7 mm HG | Standard Deviation 8.6 |
Secondary
Trough Sitting Systolic Blood Pressure
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.
Time frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nebivolol | Trough Sitting Systolic Blood Pressure | Baseline | 134.1 mm HG | Standard Deviation 12.5 |
| Nebivolol | Trough Sitting Systolic Blood Pressure | Change from baseline | 3.5 mm HG | Standard Deviation 12.3 |
| Placebo | Trough Sitting Systolic Blood Pressure | Baseline | 134.4 mm HG | Standard Deviation 11.4 |
| Placebo | Trough Sitting Systolic Blood Pressure | Change from baseline | 7.6 mm HG | Standard Deviation 11.8 |