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

• ClinicalTrials.gov Identifier: NCT00142584
• Recruitment Status: Completed
• First Posted: September 2, 2005
• Last Update Posted: March 12, 2008
• Sponsor: Mylan Bertek Pharmaceuticals
• Information provided by: Mylan Bertek Pharmaceuticals

Study Description

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

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Nebivolol; Drug: Metoprolol	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Randomized Study Evaluating the Long-Term Effects of Metoprolol Versus Nebivolol as Monotherapy or in Combination With Amlodipine or Hydrochlorothiazide for the Treatment of Patients With Hypertension
• Study Start Date: August 2005
• Estimated Primary Completion Date: March 2008
• Actual Study Completion Date: March 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1-NEB; Nebivolol	Drug: Nebivolol; Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.
Active Comparator: 2-MET; Metoprolol	Drug: Metoprolol; Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.

Outcome Measures

Primary Outcome Measures :

1. Change in average sitting DBP taken at trough at the end of treatment compared to baseline (baseline is defined as the baseline of the feeder study). [ Time Frame: During study. ]

Secondary Outcome Measures :

1. SBP, pulse pressure and heart rate at peak and trough drug effects measured in the supine, sitting and standing positions. [ Time Frame: During study. ]
2. Adverse events, ECGs, laboratory evaluations [ Time Frame: During study. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Completion of previous nebivolol study
• Stage 1-2 HTN at baseline of first study

Exclusion Criteria:

• Recent myocardial infarction or stroke
• Contraindications to beta blocker therapy

Contacts and Locations

Locations

United States, West Virginia

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Mylan Bertek Pharmaceuticals

Investigators

• Study Director: Betty S Riggs, MD, MBA; Mylan Pharmaceuticals

More Information

• Responsible Party: Andrea Miller, Vice President-Regulatory Affairs, Mylan Inc.
• ClinicalTrials.gov Identifier: NCT00142584
• Other Study ID Numbers: NEB324
• First Posted: September 2, 2005
• Last Update Posted: March 12, 2008
• Last Verified: August 2005

Keywords provided by Mylan Bertek Pharmaceuticals:

safety and tolerability study; hypertension; beta-blockers

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Metoprolol; Nebivolol; Anti-Arrhythmia Agents; Antihypertensive Agents; Sympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Adrenergic beta-1 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists