Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension

Detailed Description
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Approximately 50 million Americans have hypertension defined as a systolic blood pressure (SBP) greater then or equal to 140 mmHg and/or a diastolic blood pressure (DBP) greater then or equal to 90 mmHg. To control blood pressure, more than 2 agents are required in many patients. The current study is a randomized, titration-to-effect, open-label, multi center study. Patients will be randomized to either nebivolol or metoprolol. The dose of the randomized treatment can be titrated as needed to achieve blood pressure control. If necessary, additional antihypertensive agents (calcium antagonist, diuretic, etc.) can be added to achieve control. Patients will be seen every 1-3 months for approximately 18 months to assess long-term safety, tolerability and effectiveness of nebivolol versus metoprolol.

Official Title
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An Open-label, Randomized Study Evaluating the Long-term Effects of Metoprolol (MET) Versus Nebivolol (NEB) as Monotherapy or in Combination With Amlodipine or Hydrochlorothiazide for the Treatment of Patients With Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Nebivolol (NEB)
* Drug: Metoprolol (MET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completion of previous nebivolol study Stage 1-2 Hypertension (HTN) at baseline of first study Exclusion Criteria: Recent myocardial infarction or stroke Contraindications to beta blocker therapy

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-NEB<br>Nebivolol | Drug: Nebivolol (NEB)<br>* Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.<br>|
| Active Comparator: 2-MET<br>Metoprolol | Drug: Metoprolol (MET)<br>* Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline | The primary efficacy parameter was the change in the average trough sitting DBP at the end of treatment (Visit 10 or Early Termination) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 [NCT00145210]). | Through study duration (approximately 18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | Data for the analysis of the change from baseline in mean trough sitting DBP at each study visit (Visits 1 through 9) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 [NCT00145210]) by treatment group are provided below. | Through study completion (approximately 18 months) | 
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Summary of Participants that experienced one or more TEAEs by Treatment Group-Safety Population | Through study completion (approximately 18 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety and tolerability study, hypertension, beta-blockers