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 and metoprolol	Phase III

Further Study Details: 

Primary Outcomes: 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).
Secondary Outcomes: SBP, pulse pressure and heart rate at peak and trough drug effects measured in the supine, sitting and standing positions.; Adverse events, ECGs, laboratory evaluations
Expected Total Enrollment:  1000

Approximately 50 milllion 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00142584

Will A Sullivan, BS      304-554-6587    Will.Sullivan@mylanlabs.com
P J Guyton, BS      304-599-2595  Ext. 6693    PJ.Guyton@mylanlabs.com

West Virginia
      Mylan Pharmaceuticals Inc., Morgantown,  West Virginia,  26505,  United States; Recruiting

Study chairs or principal investigators

Betty S Riggs, MD, MBA,  Study Director,  Mylan Pharmaceuticals Inc.   

Study ID Numbers:  NEB324; Not Applicable
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00142584
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06