Status:

COMPLETED

A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

Lead Sponsor:

Forest Laboratories

Conditions:

Hypertension

Eligibility:

All Genders

18-79 years

Phase:

PHASE4

Brief Summary

This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.

Eligibility Criteria

Inclusion

  • male and female outpatients 18 to 79 years of age
  • Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
  • meet criteria for stage I or II hypertension
  • currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion

  • type 1 or type 2 diabetes
  • secondary hypertension
  • evidence of other concurrent disease or conditions that might interfere with the conduct of the study
  • treatment with any investigational study drug within 30 days of Screening (Visit 1)
  • have a history of hypersensitivity to nebivolol or other β-blockers

Key Trial Info

Start Date :

November 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

207 Patients enrolled

Trial Details

Trial ID

NCT00785512

Start Date

November 1 2008

Last Update

September 15 2010

Active Locations (26)

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Page 1 of 7 (26 locations)

1

Forest Investigative Site

Chandler, Arizona, United States, 85225

2

Forest Investigative Site

Phoenix, Arizona, United States, 85050

3

Forest Investigative Site

Los Angeles, California, United States, 90057

4

Forest Investigative Site

Bradenton, Florida, United States, 34203