Status:
COMPLETED
Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension
Lead Sponsor:
Forest Laboratories
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.
Eligibility Criteria
Inclusion
- Male or female outpatients of age 18 years or above
- Patients diagnosed with stage 1 or stage 2 essential hypertension
- Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant
Exclusion
- Secondary hypertension or severe hypertension
- Clinically significant cardiovascular disease or heart failure
- A medical contraindication to discontinuing a current antihypertensive therapy
- History of Type 1 diabetes mellitus
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
812 Patients enrolled
Trial Details
Trial ID
NCT01415505
Start Date
August 1 2011
End Date
April 1 2013
Last Update
June 4 2013
Active Locations (135)
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1
Forest Investigative Site 083
Birmingham, Alabama, United States, 35216
2
Forest Investigative Site 004
Foley, Alabama, United States, 36535
3
Forest Investigative Site 038
Gulf Shores, Alabama, United States, 36542
4
Forest Investigative Site 124
Muscle Shoals, Alabama, United States, 35662