A Phase 4 interventional study of Nebivolol and Placebo in Hypertension, sponsored by Forest Laboratories. Completed at 36 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2012-01-11.
Sponsored by Forest Laboratories (part of AbbVie) · Phase 4, Interventional, and Treatment
The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 433 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Forest Laboratories is the lead sponsor of 168 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.
First submitted before Forest Laboratories became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Drug: Nebivolol
Drug: Placebo
5 mg, titrated to 20 mg, once daily oral administration
Also known as: Bystolic
5 mg or 20 mg once daily, oral administration
Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
Office blood pressure measured at trough by automatic oscillometric device.
Time frame: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)
Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
Office blood pressure measured at trough by automatic oscillometric device.
Time frame: Change from Baseline (Week 0) to Visit 4 (Week 6)
Recruitment occured from March 2010 through October 2010 at 36 US sites.
| Milestone | Nebivolol | Placebo |
|---|---|---|
| Started | 290 | 143 |
| Completed | 262 | 114 |
| Not completed | 28 | 29 |
| Withdrew: Did not meet inclusionexclusion criteria | 4 | 2 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Lack of efficacy | 2 | 11 |
| Withdrew: Protocol violation | 6 | 2 |
| Withdrew: Withdrawal by subject | 4 | 5 |
| Withdrew: Lost to follow-up | 7 | 6 |
| Withdrew: Other reason | 1 | 1 |
Office blood pressure measured at trough by automatic oscillometric device.
| mm Hg | Nebivolol | Placebo |
|---|---|---|
| Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | -18.2 ± 16.7 | -12.3 ± 17.7 |
Office blood pressure measured at trough by automatic oscillometric device.
| mm Hg | Nebivolol | Placebo |
|---|---|---|
| Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | -12.3 ± 9.8 | -5.7 ± 11.4 |
Collected over Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebivolol | — | 1/290 (0.3%) | 0/290 (0%) |
| Placebo | — | 3/142 (2.1%) | 0/142 (0%) |
| Event | Nebivolol | Placebo |
|---|---|---|
| Myofascial pain syndromeMusculoskeletal and connective tissue disorders | 0/290 | 1/142 |
| Chest PainGeneral disorders | 0/290 | 1/142 |
| HypertensionVascular disorders | 0/290 | 1/142 |
| Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/290 | 1/142 |
| AnaemiaBlood and lymphatic system disorders | 1/290 | 0/142 |
| Age, Categorical(Participants) | Nebivolol | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 290 | 142 | 432 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Nebivolol | Placebo | Total |
|---|---|---|---|
| Mean | 51.1 ± 8.1 | 49.7 ± 9.0 | 50.6 ± 8.4 |
| Sex: Female, Male(Participants) | Nebivolol | Placebo | Total |
|---|---|---|---|
| Female | 141 | 61 | 202 |
| Male | 149 | 81 | 230 |
| Region of Enrollment(participants) | Nebivolol | Placebo | Total |
|---|---|---|---|
| United States | 290 | 142 | 432 |
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nebivolol