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

This study has been completed.
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00142584
First received: August 31, 2005
Last updated: March 6, 2008
Last verified: August 2005
History of Changes
  Purpose

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 Intervention Phase
Hypertension
 Drug: Nebivolol
Drug: Metoprolol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mylan Bertek Pharmaceuticals:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SBP, pulse pressure and heart rate at peak and trough drug effects measured in the supine, sitting and standing positions. [ Time Frame: During study. ] [ Designated as safety issue: No ]
  • Adverse events, ECGs, laboratory evaluations [ Time Frame: During study. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2005
Study Completion Date: March 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142584

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

No publications provided

Responsible Party: Andrea Miller, Vice President-Regulatory Affairs, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00142584     History of Changes
Other Study ID Numbers: NEB324
Study First Received: August 31, 2005
Last Updated: March 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Mylan Bertek Pharmaceuticals:
safety and tolerability study
hypertension
beta-blockers

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nebivolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on May 16, 2013