Hypertension
Conditions
Keywords
nebivolol, Bystolic ™, Hypertension, Hispanic, Hypertension in Hispanic patients
Brief summary
This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension
Interventions
DRUGNebivolol
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration 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 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female outpatients 18 to 80 years of age, self-identified as Hispanic or Latino ethnicity * 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
* Secondary hypertension * Are taking three or more antihypertensive agents * Have uncontrolled or poorly controlled diabetes mellitus type I or type II * Evidence of other concurrent disease or conditions that might interfere with the conduct of the study * Participation in any investigational study within 30 days of Screening (Visit 1). * Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Seated DBP at Week 8(LOCF). | From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8) | The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF). | From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8) | The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
The recruitment period was one year, from November 2008 to November 2009, occurring at 29 centers in the US and 3 centers in Puerto Rico.
Pre-assignment details
All patients went through a 4 week, single blind, placebo run-in/washout phase before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Nebivolol Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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 | 141 |
| Placebo Matching placebo tablets, oral administration | 136 |
| Total | 277 |
Baseline characteristics
| Characteristic | Nebivolol | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 135 Participants | 129 Participants | 264 Participants |
| Age Continuous | 50.4 years STANDARD_DEVIATION 8.7 | 50.4 years STANDARD_DEVIATION 8.7 | 50.4 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment Puerto Rico | 7 participants | 5 participants | 12 participants |
| Region of Enrollment United States | 134 participants | 131 participants | 265 participants |
| Sex: Female, Male Female | 62 Participants | 51 Participants | 113 Participants |
| Sex: Female, Male Male | 79 Participants | 85 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 141 | 8 / 136 |
| serious Total, serious adverse events | 0 / 141 | 1 / 136 |
Outcome results
Primary
Change From Baseline in Trough Seated DBP at Week 8(LOCF).
The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.
Time frame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Change From Baseline in Trough Seated DBP at Week 8(LOCF). | -11.1 mm Hg | Standard Deviation 8.8 |
| Placebo | Change From Baseline in Trough Seated DBP at Week 8(LOCF). | -7.3 mm Hg | Standard Deviation 8.9 |
Comparison: H0 - There was no difference in BP reduction between Neb and Placebo. The efficacy analyses were based on the ITT population for the double-blind treatment phase. The LOCF was used to impute missing postbaseline values. Sensitivity analyses were based on observed cases for all efficacy parameters. All statistical tests were two-sided hypothesis tests performed at the 5% level of significance for main effects. All confidence intervals were two-sided 95% confidence intervals.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).
The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.
Time frame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF). | -14.1 mm Hg | Standard Deviation 12.7 |
| Placebo | Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF). | -9.3 mm Hg | Standard Deviation 13 |
p-value: 0.001ANCOVA