The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.

Official Title
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Efficacy and Tolerability of Nebivolol Compared With Carvedilol in Patients With Coronary Artery Disease and Stage I or II Hypertension

Conditions
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Hypertension, Coronary Artery Disease

Intervention / Treatment
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* Drug: Nebivolol
* Drug: Carvedilol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ambulatory outpatients 18 to 85 of age at screening Coronary artery disease as defined by: status post myocardial infarction (heart attack) greater than 14 days post event with no upper time limit (and followed by stress testing with additional imaging (echocardiographic or nuclear) within the 12 months prior to enrollment) and/or angiographic evidence of one or more major coronary arteries narrowing of greater than 50% and/or a history of percutaneous or surgical coronary revascularization greater than 4 months after that procedure at the time of enrollment. Qualifying blood pressure criteria for study entry and for randomization Willing to adhere to exercise stress (treadmill) tests Exclusion Criteria: Unstable angina within 7 days of screening Potential coronary surgical/intervention within the next 6 months Have any form of secondary hypertension Have a history of hypersensitivity to nebivolol, metoprolol, carvedilol, or any beta blocker

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: 1<br>Encapsulated Nebivolol | Drug: Nebivolol<br>* Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily<br>* Other names: Bystolic;|
| Active Comparator: 2<br>Encapsulated Carvedilol | Drug: Carvedilol<br>* Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily<br>* Other names: Coreg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Diastolic Blood Pressure (DBP) | Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18) | 18 weeks post initiation of randomized treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Systolic Blood Pressure (SBP) | Peripheral systolic blood pressure (SBP) at visit 13 (week 18) | 18 weeks post initiation of randomized treatment | 
| Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18 | Proportion of Patients with Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18 | 18 weeks post-treatment | 
| Left Ventricular Ejection Fraction (LVEF) (%) at Week 18 | Left ventricular ejection fraction (LVEF) (%) at Week 18 | 18 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carvedilol, Coreg (TM), hypertension, blood pressure, coronary artery disease, Nebivolol, BYSTOLIC (TM)