Status:
COMPLETED
A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients
Lead Sponsor:
Mylan Bertek Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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,...
Detailed Description
This was an international, multicenter parallel group, 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Secondary hypertension
- myocardial infarction or stroke
- contraindications to beta-blocker therapy
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2003
Estimated Enrollment :
845 Patients enrolled
Trial Details
Trial ID
NCT00200499
Start Date
March 1 2002
End Date
September 1 2003
Last Update
December 16 2005
Active Locations (1)
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1
Mylan Pharmaceuticals Inc.
Morgantown, West Virginia, United States, 26505