Status:
COMPLETED
Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension
Lead Sponsor:
Forest Laboratories
Conditions:
Stage 1 Hypertension
Stage 2 Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 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
- Clinical significant respiratory disease that would prohibit the use of a beta blocker
- A medical contraindication to discontinuing a current antihypertensive therapy
- History of Type 1 diabetes mellitus
- History of Severe Mental Illness except mild depression
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
4161 Patients enrolled
Trial Details
Trial ID
NCT01508026
Start Date
January 1 2012
End Date
May 1 2013
Last Update
April 25 2014
Active Locations (413)
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1
Forest Investigative Site 1750
Birmingham, Alabama, United States, 35216
2
Forest Investigative Site 1038
Birmingham, Alabama, United States, 35235
3
Forest Investigative Site 1308
Birmingham, Alabama, United States, 35235
4
Forest Investigative Site 1192
Birmingham, Alabama, United States, 35242