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: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Nebivolol; Valsartan

Criteria

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