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

NCT ID: NCT00142584

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2008-03-31

Brief Summary

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

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1-NEB

Nebivolol

Group Type: EXPERIMENTAL

Nebivolol (NEB)

Intervention Type: DRUG

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

2-MET

Metoprolol

Group Type: ACTIVE_COMPARATOR

Metoprolol (MET)

Intervention Type: DRUG

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

Interventions

Nebivolol (NEB)

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

Intervention Type: DRUG

Metoprolol (MET)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mylan Bertek Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betty S Riggs, MD, MBA

Role: STUDY_DIRECTOR

Mylan Pharmaceuticals Inc

Locations

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

NEB324

Identifier Type: -

Identifier Source: org_study_id