Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Nebivolol
  • Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
• Placebo Comparator: Placebo
  • Matching placebo tablets, oral administration

Primary Measures

• Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12
  • Time Frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)
    Safety Issue?: No

Secondary Measures

• Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12
  • Time Frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)
    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 kidney disease
• Documented congestive heart failure
• Have clinically significant respiratory, liver, or heart disease
• History of stroke, heart attack, or heart surgery in the last 6 months
• Have a history of hypersensitivity to nebivolol or other beta blockers.

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 Investigator: Forest Laboratories Industry

Overall Clinical Trial Officials and Contacts

Manfred Stapff, MD, PhD Study Director Forest Research Institute, a subsidiary of Forest Laboratories, Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

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