Conditions: Hypertension
Keywords: safety and tolerability study hypertension beta-blockers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 336
Healthy volunteers: no

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.

Arms:
arm 1: Nebivolol arm 2: Metoprolol

Interventions: intervention 1: Nebivolol (NEB) intervention 2: Metoprolol (MET)
Intervention descriptions: intervention 1: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks. intervention 2: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.

Protocol document: