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

Mylan Bertek Pharmaceuticals336 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

336

Conditions

Hypertension

Interventions

Nebivolol (NEB)DRUG

Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.

Metoprolol (MET)DRUG

Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

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 \[NCT00145210\]).

Time frame: Through study duration (approximately 18 months)

Secondary Outcomes

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.

Time frame: 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

Time frame: Through study completion (approximately 18 months)

Data from ClinicalTrials.gov

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