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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00142584
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : March 12, 2008
Information provided by:
Mylan Bertek Pharmaceuticals

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.

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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

Arm Intervention/treatment
Experimental: 1-NEB
Drug: Nebivolol
Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.

Active Comparator: 2-MET
Drug: Metoprolol
Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.

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. ]

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00142584

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United States, West Virginia
Mylan Pharmaceuticals Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Bertek Pharmaceuticals
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Study Director: Betty S Riggs, MD, MBA Mylan Pharmaceuticals
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Responsible Party: Andrea Miller, Vice President-Regulatory Affairs, Mylan Inc. Identifier: NCT00142584    
Other Study ID Numbers: NEB324
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: March 12, 2008
Last Verified: August 2005
Keywords provided by Mylan Bertek Pharmaceuticals:
safety and tolerability study
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
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