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



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:January 2012
Contact:Sandra Beaird, PhD
Email:info@forestpharm.com
Phone:1-800-678-1605

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A Multicenter, Randomized, Double-blind, Placebo-Controlled, 8-Week Study to Evaluate the Safety and Efficacy of Nebivolol and Valsartan Given as a Fixed Dose Combination in Patients With Stage 1 or 2 Essential Hypertension


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.


Inclusion Criteria:

- 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 Criteria:

- 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
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