Evaluation of the Long-Term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
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ClinicalTrials.gov Identifier: NCT00142584 |
Recruitment Status :
Completed
First Posted : September 2, 2005
Last Update Posted : March 12, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Nebivolol Drug: Metoprolol | Phase 3 |
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
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. |
- 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. ]
- SBP, pulse pressure and heart rate at peak and trough drug effects measured in the supine, sitting and standing positions. [ Time Frame: During study. ]
- Adverse events, ECGs, laboratory evaluations [ Time Frame: During study. ]

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00142584
United States, West Virginia | |
Mylan Pharmaceuticals Inc. | |
Morgantown, West Virginia, United States, 26505 |
Study Director: | Betty S Riggs, MD, MBA | Mylan Pharmaceuticals |
Responsible Party: | Andrea Miller, Vice President-Regulatory Affairs, Mylan Inc. |
ClinicalTrials.gov 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 |
safety and tolerability study hypertension beta-blockers |
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 |