Status:

COMPLETED

A Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Hypertension

Lead Sponsor:

Mylan Bertek Pharmaceuticals

Conditions:

Hypertension

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study was to contrast the efficacy and safety of 3 dose levels of nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for 3 months, in patients...

Detailed Description

Following a washout of any previous beta-blocker medication, if applicable, supine, sitting, and standing cuff blood pressure and pulse rate, 24-hour ambulatory blood pressure monitoring (ABPM), ECG, ...

Eligibility Criteria

Inclusion

  • Average sitting diastolic blood pressure (DBP) greater then or equal to 90 mmHg and less then or equal to 109 mmHg at screening and baseline, in patients on background antihypertensive therapy taking at least one and no more than two of either ACE inhibitor, ARB, or diuretic.

Exclusion

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

Key Trial Info

Start Date :

October 1 2002

Trial Type :

INTERVENTIONAL

End Date :

October 1 2003

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT00200434

Start Date

October 1 2002

End Date

October 1 2003

Last Update

September 20 2005

Active Locations (1)

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1

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, United States, 26505