Status:
COMPLETED
Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)
Lead Sponsor:
Forest Laboratories
Conditions:
Hypertension
Eligibility:
All Genders
18-54 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or sta...
Eligibility Criteria
Inclusion
- Male and female outpatients, of age 18 - 54 years
- Patients diagnosed with stage 1 or stage 2 essential hypertension
- Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant
Exclusion
- Secondary hypertension or severe hypertension
- History of Type 1 diabetes mellitus
- A medical contraindication to discontinuing a current antihypertensive therapy
- Clinically significant respiratory disease that prohibit use of a beta blocker
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
641 Patients enrolled
Trial Details
Trial ID
NCT01415531
Start Date
August 1 2011
End Date
April 1 2012
Last Update
May 16 2013
Active Locations (75)
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1
Forest Investigative Site 065
Phoenix, Arizona, United States, 85014
2
Forest Investigative Site 067
Phoenix, Arizona, United States, 85014
3
Forest Investigative Site 070
Phoenix, Arizona, United States, 85014
4
Forest Investigative Site 049
Buena Park, California, United States, 90620