A Phase 4 interventional study of Nebivolol and Placebo in Hypertension, sponsored by Forest Laboratories. Completed at 26 sites in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2010-09-15.
Sponsored by Forest Laboratories · Phase 4, Interventional, and Treatment
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 207 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Nebivolol
Matching placebo tablets, oral administration
Drug: Placebo
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
Also known as: Bystolic® (nebivolol)
Matching placebo tablets, oral administration
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)
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)
The recruitment period was five months, from November 2008 through March 2009.
| Milestone | Nebivolol | Placebo |
|---|---|---|
| Started | 102 | 105 |
| Completed | 99 | 101 |
| Not completed | 3 | 4 |
| Withdrew: Inclusion/exclusion not meet | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Precedure refused | 0 | 0 |
| Withdrew: Ivrs programing error | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 |
| Withdrew: Lack of compliance | 0 | 1 |
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.
| mm HG | Nebivolol | Placebo |
|---|---|---|
| Baseline | 81.3 ± 7.2 | 81.1 ± 7.0 |
| Change from baseline | 1.8 ± 7.3 | 7.7 ± 8.6 |
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.
| mm HG | Nebivolol | Placebo |
|---|---|---|
| Baseline | 134.1 ± 12.5 | 134.4 ± 11.4 |
| Change from baseline | 3.5 ± 12.3 | 7.6 ± 11.8 |
Collected over Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single-blind Nebivolol | — | 2/269 (0.7%) | 29/269 (10.8%) |
| Nebivolol | — | 0/102 (0%) | 0/102 (0%) |
| Placebo | — | 0/105 (0%) | 0/105 (0%) |
| Event | Single-blind Nebivolol | Nebivolol | Placebo |
|---|---|---|---|
| Acute myocardial infarctionCardiac disorders | 1/269 | 0/102 | 0/105 |
| PneumoniaInfections and infestations | 1/269 | 0/102 | 0/105 |
| SepsisInfections and infestations | 1/269 | 0/102 | 0/105 |
| Event | Single-blind Nebivolol | Nebivolol | Placebo |
|---|---|---|---|
| BradycardiaCardiac disorders | 16/269 | 0/102 | 0/105 |
| NasopharyngitisInfections and infestations | 14/269 | 0/102 | 0/105 |
| Age Categorical(participants) | Nebivolol | Placebo | Total |
|---|---|---|---|
| <18 years | 0 | 0 | 0 |
| Ages 18 to 64 years | 86 | 91 | 177 |
| >=65 years | 16 | 14 | 30 |
| Age Continuous(years) | Nebivolol | Placebo | Total |
|---|---|---|---|
| Mean | 52.6 ± 11.2 | 52.9 ± 10.2 | 52.8 ± 10.6 |
| Sex: Female, Male(Participants) | Nebivolol | Placebo | Total |
|---|---|---|---|
| Female | 43 | 43 | 86 |
| Male | 59 | 62 | 121 |
| Region of Enrollment(participants) | Nebivolol | Placebo | Total |
|---|---|---|---|
| United States | 102 | 105 | 207 |
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Forest Laboratories