Hypertension
Conditions
Keywords
Stage 1, Stage 2, Hypertension
Brief summary
The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.
Interventions
DRUGNebivolol
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
DRUGPlacebo
Dose-match placebo
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
No
Inclusion criteria
* Male and female outpatients, of age 18 - 54 years * Patients diagnosed with stage 1 or stage 2 essential hypertension * Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant
Exclusion criteria
* Secondary hypertension or severe hypertension * History of Type 1 diabetes mellitus * A medical contraindication to discontinuing a current antihypertensive therapy * Clinically significant respiratory disease that prohibit use of a beta blocker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough Seated Diastolic Blood Pressure (DBP) | Change from Baseline to Week 8 | Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trough Seated Systolic Blood Pressure (SBP) | Change from Baseline to Week 8 | Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach. |
Countries
United States
Participant flow
Recruitment details
Patient recruitment occurred over a 4 month period from August 2011 to December 2011 at 76 study sites in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Dose-matched placebo | 214 |
| Nebivolol Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration | 427 |
| Total | 641 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 10 |
| Overall Study | Lack of Compliance | 1 | 4 |
| Overall Study | Lack of Efficacy | 3 | 2 |
| Overall Study | Lost to Follow-up | 6 | 14 |
| Overall Study | Other Reasons | 3 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Placebo | Nebivolol | Total |
|---|---|---|---|
| Age Continuous 18 to 54 | 46.0 years STANDARD_DEVIATION 6.9 | 44.9 years STANDARD_DEVIATION 6.9 | 45.3 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment United States | 214 participants | 427 participants | 641 participants |
| Sex: Female, Male Female | 95 Participants | 190 Participants | 285 Participants |
| Sex: Female, Male Male | 119 Participants | 237 Participants | 356 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 214 | 37 / 427 |
| serious Total, serious adverse events | 4 / 214 | 4 / 427 |
Outcome results
Primary
Trough Seated Diastolic Blood Pressure (DBP)
Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Time frame: Change from Baseline to Week 8
Population: 641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Trough Seated Diastolic Blood Pressure (DBP) | -5.5 mmHG | Standard Deviation 9.5 |
| Nebivolol | Trough Seated Diastolic Blood Pressure (DBP) | -11.8 mmHG | Standard Deviation 8.8 |
p-value: <0.000195% CI: [-7.7, -4.8]ANCOVA
Secondary
Trough Seated Systolic Blood Pressure (SBP)
Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Time frame: Change from Baseline to Week 8
Population: 641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Trough Seated Systolic Blood Pressure (SBP) | -5.5 mm Hg | Standard Deviation 13.9 |
| Nebivolol | Trough Seated Systolic Blood Pressure (SBP) | -13.7 mm Hg | Standard Deviation 14.5 |