Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

Study Overview
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Brief Summary
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This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Nebivolol Added To Antihypertensive Treatment With Lisinopril or Losartan in Patients With 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 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 | Drug: nebivolol<br>* 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<br>* Other names: Bystolic ™;|
| Placebo Comparator: Placebo<br>Matching placebo tablets, oral administration | Drug: Placebo<br>* Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration<br>* Other names: Losartan-other name: Cozaar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | From baseline Visit 5 (Week 0) to Visit 10 (Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | From baseline Visit 5 (Week 0) to Visit 10 (Week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nebivolol, Bystolic ™, lisinopril, losartan, Hypertension