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

• ClinicalTrials.gov Identifier: NCT00142584
• Recruitment Status: Completed
• First Posted: September 2, 2005
• Last Update Posted: March 12, 2008
• Sponsor: Mylan Bertek Pharmaceuticals
• Information provided by: Mylan Bertek Pharmaceuticals

Tracking Information

• First Submitted Date: August 31, 2005
• First Posted Date: September 2, 2005
• Last Update Posted Date: March 12, 2008
• Study Start Date: August 2005
• Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 6, 2008): 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. ]
• Original Primary Outcome Measures (submitted: August 31, 2005): 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).

Current Secondary Outcome Measures (submitted: March 6, 2008)

• 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. ]

Original Secondary Outcome Measures (submitted: August 31, 2005)

• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the Long-Term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
• 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
• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• 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.

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: August 31, 2005): 1000
• Original Enrollment: Same as current
• Actual Study Completion Date: March 2008
• Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00142584
• Other Study ID Numbers: NEB324
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Andrea Miller, Vice President-Regulatory Affairs, Mylan Inc.
• Study Sponsor: Mylan Bertek Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Betty S Riggs, MD, MBA; Mylan Pharmaceuticals

• PRS Account: Mylan Bertek Pharmaceuticals
• Verification Date: August 2005