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

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Mylan

Status and phase

Completed
Phase 3

Conditions

Hypertension

Treatments

Drug: Nebivolol (NEB)
Drug: Metoprolol (MET)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

336 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Completion of previous nebivolol study
  • Stage 1-2 Hypertension (HTN) at baseline of first study

Exclusion criteria

  • Recent myocardial infarction or stroke
  • Contraindications to beta blocker therapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

336 participants in 2 patient groups

1-NEB
Experimental group
Description:
Nebivolol
Treatment:
Drug: Nebivolol (NEB)
2-MET
Active Comparator group
Description:
Metoprolol
Treatment:
Drug: Metoprolol (MET)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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