Official Title: “A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Nebivolol Added to Antihypertensive Treatment With Lisinopril or Losartan in Patients With Hypertension”

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: nebivolol
  • Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily
• Drug: lisinopril
  • Lisinopril 10 mg, 20 mg total daily dosage, oral administration
• Drug: losartan
  • Losartan 50 mg 100 mg total daily dosage, oral administration

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily
• Placebo Comparator: 2
  • Lisinopril 10 mg, 20 mg total daily dosage, oral administration
• Placebo Comparator: 3
  • Losartan 50 mg 100 mg total daily dosage, oral administration

Primary Measures

• Change from baseline in mean seated systolic blood pressure (SBP) at week 12
  • Time Frame: Before treatment and 12 weeks after treatment
    Safety Issue?: No

Secondary Measures

• Change from baseline in mean seated diastolic blood pressure (DBP) at week 12
  • Time Frame: Before treatment and 12 weeks after treatment
    Safety Issue?: No

Inclusion Criteria:

• Male or female, ambulatory outpatients 18-85 years old at screening.
• Have a history of hypertension
• Qualifying laboratory results

Exclusion Criteria:

• Severe Hypertension, including chronic renal disease
• Documented Congested Heart Failure
• Works night shift
• Type I or Type II diabetes
• Have clinically significant respiratory, liver or cardiovascular disease
• Presence of coronary artery disease requiring treatment with a beta blocker, calcium channel blocker or nitrates
• Have a history of hypersensitivity to nebivolol, other beta-blockers, or other sulfonamide-derived drugs.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Forest Laboratories

Overall Clinical Trial Officials and Contacts

Overall Contact: Sandra Beaird, PhD 800-678-1605 info@forestpharm.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00734630

Study ID Number: NEB-MD-11

ClinicalTrials.gov Identifier: NCT00734630

Health Authority: United States: Food and Drug Administration