A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension

Official Title
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A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled, Dose-Titration Study of Nebivolol Monotherapy in Hispanic Patients With Stage 1 or Stage 2 Hypertension

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 80 years of age, self-identified as Hispanic or Latino ethnicity 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: Secondary hypertension Are taking three or more antihypertensive agents Have uncontrolled or poorly controlled diabetes mellitus type I or type II Evidence of other concurrent disease or conditions that might interfere with the conduct of the study Participation in any investigational study within 30 days of Screening (Visit 1). Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Nebivolol<br>Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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 5 mg, 5-mg Nebivolol nontrade tablets , oral administration 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 (TM);|
| Placebo Comparator: Placebo<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 |
| --- | --- | --- |
| Change From Baseline in Trough Seated DBP at Week 8(LOCF). | The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value. | From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF). | The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value. | From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nebivolol, Bystolic ™, Hypertension, Hispanic, Hypertension in Hispanic patients