A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Nebivolol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female outpatients 18 to 79 years of age 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: type 1 or type 2 diabetes secondary hypertension evidence of other concurrent disease or conditions that might interfere with the conduct of the study treatment with any investigational study drug within 30 days of Screening (Visit 1) have a history of hypersensitivity to nebivolol or other β-blockers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* 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<br>* Other names: Bystolic® (nebivolol);|
| Placebo Comparator: 2<br>Matching placebo tablets, oral administration | Drug: Placebo<br>* Matching placebo tablets, oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline, week 0 (Visit 9) to week 4 (Visit 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline, week 0 (Visit 9) to week 4 (Visit 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nebivolol, Bystolic®, Hypertension, blood pressure, withdrawal