Evaluation of the Long-Term Safety and Tolerability of Metoprolol Versus Nebivolol in 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 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|
- 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 ]
- 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 ]
|Study Start Date:||August 2005|
|Study Completion Date:||March 2008|
|Estimated Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.
Active Comparator: 2-MET
Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.
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.
|United States, West Virginia|
|Mylan Pharmaceuticals Inc.|
|Morgantown, West Virginia, United States, 26505|
|Study Director:||Betty S Riggs, MD, MBA||Mylan Pharmaceuticals|