A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients

Completed · Phase 3

Conditions studied: Hypertension

In brief

The study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension. This was an extension of the Phase III dose ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy.

Key facts

Study ID

NCT00200499

Run by

Mylan Bertek Pharmaceuticals

People needed

845

Starts

2002-03-01

Expected to finish

2003-09-01

Last updated by the study team

2005-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To enter the long-term treatment phase, patients must have successfully completed NEB 202, NEB 302, or NEB 305. To enter the 4-week follow-up phase, patients must have completed NEB-306 (extension phase) and received only nebivolol monotherapy treatment during NEB 306.

You may not qualify if…

• Secondary hypertension
• myocardial infarction or stroke
• contraindications to beta-blocker therapy

Where it is running

• Mylan Pharmaceuticals Inc. — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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