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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: March 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Nebivolol
  • Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.
• Drug: Metoprolol
  • Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1-NEB
  • Nebivolol
• Active Comparator: 2-MET
  • Metoprolol

Primary 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.
    Safety Issue?: No

Secondary 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.
    Safety Issue?: No
• Adverse events, ECGs, laboratory evaluations
  • Time Frame: During study.
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mylan Bertek Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Betty S Riggs, MD, MBA Study Director Mylan Pharmaceuticals  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00142584

Study ID Number: NEB324

ClinicalTrials.gov Identifier: NCT00142584

Health Authority: United States: Food and Drug Administration