Hypertension
Conditions
Keywords
nebivolol, Bystolic ™, lisinopril, losartan, Hypertension
Brief summary
This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.
Interventions
DRUGnebivolol
Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration
DRUGPlacebo
Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total 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 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, ambulatory outpatients 18-85 years old at screening * Have a history of hypertension * Qualifying laboratory results
Exclusion criteria
* Severe hypertension, including chronic kidney disease * Documented congestive heart failure * Have clinically significant respiratory, liver, or heart disease * History of stroke, heart attack, or heart surgery in the last 6 months * Have a history of hypersensitivity to nebivolol or other beta blockers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12 | From baseline Visit 5 (Week 0) to Visit 10 (Week 12) | Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12 | From baseline Visit 5 (Week 0) to Visit 10 (Week 12) | Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF). |
Countries
United States
Participant flow
Recruitment details
Recruitment occured from August 2008 through November 2009 at 76 US sites.
Pre-assignment details
Placebo washout phase was required for patients currently on anti-hypertensives at screening followed by a losartan or lisinopril run-in phase before assignment to Placebo or Nebivolol arms. Patients who were untreated at screening started the study at the open-label lead-in phase.
Participants by arm
| Arm | Count |
|---|---|
| Nebivolol Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration | 258 |
| Placebo Matching placebo tablets, oral administration | 233 |
| Total | 491 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 6 |
| Overall Study | Inclusion/Exclusion criteria not met | 0 | 1 |
| Overall Study | Lack of Efficacy | 4 | 4 |
| Overall Study | Lost to Follow-up | 13 | 7 |
| Overall Study | Poor Compliance | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | Randomized in Error | 0 | 1 |
| Overall Study | Tested Positive for Illegal Drug Use | 1 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 9 |
Baseline characteristics
| Characteristic | Nebivolol | Placebo | Total |
|---|---|---|---|
| Age Continuous | 52.1 years STANDARD_DEVIATION 10.1 | 53.8 years STANDARD_DEVIATION 9.6 | 52.9 years STANDARD_DEVIATION 9.9 |
| Age, Customized ≥65 years | 29 Participants | 32 Participants | 61 Participants |
| Age, Customized Between 18 and 65 Years | 229 Participants | 201 Participants | 430 Participants |
| Region of Enrollment United States | 258 participants | 233 participants | 491 participants |
| Sex: Female, Male Female | 104 Participants | 92 Participants | 196 Participants |
| Sex: Female, Male Male | 154 Participants | 141 Participants | 295 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 258 | 0 / 233 |
| serious Total, serious adverse events | 1 / 258 | 3 / 233 |
Outcome results
Primary
Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12
Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).
Time frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12 | -10.1 mmHG | Standard Deviation 16.9 |
| Placebo | Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12 | -7.3 mmHG | Standard Deviation 15.9 |
Secondary
Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12
Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).
Time frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12 | -7.8 mmHG | Standard Deviation 10.1 |
| Placebo | Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12 | -3.5 mmHG | Standard Deviation 10.6 |