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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Andrea Miller, Vice President-Regulatory Affairs, Mylan Inc.
ClinicalTrials.gov Identifier:	NCT00142584 History of Changes
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