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

Condition(s) targeted: Hypertension

Intervention: nebivolol (Drug); lisinopril, losartan (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Manfred Stapff, MD, PhD, Study Director, Affiliation: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Overall contact:
Sandra Beaird, PhD, Phone: 800-678-1605, Ext: 66297, Email: info@forestpharm.com

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

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.

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

Primary outcome: Change from baseline in mean seated trough cuff systolic blood pressure (SBP) at Week 12

Secondary outcome: Change from baseline in mean seated trough cuff diastolic blood pressure (DBP) at Week 12.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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.

Sandra Beaird, PhD, Phone: 800-678-1605, Ext: 66297, Email: info@forestpharm.com

Forest Investigative Site 001, Westlake Village, California 91361, United States; Recruiting

Forest Investigative Site 010, Tustin, California 92780, United States; Recruiting

Forest Investigative Site 012, Bell Gardens, California 90201, United States; Recruiting

Forest Investigative Site 026, Chino, California 91710, United States; Recruiting

Forest Investigative Site 030, Los Angeles, California 90057, United States; Recruiting

Forest Investigative Site 028, Sacramento, California 95831, United States; Recruiting

Forest Investigative Site 034, Sacramento, California 95816, United States; Not yet recruiting

Forest Investigative Site 002, Miami, Florida 33135, United States; Recruiting

Forest Investigative Site 013, Miami, Florida 33169, United States; Recruiting

Forest Investigative Site 015, Deland, Florida 32720, United States; Recruiting

Forest Investigative Site 035, Fort Lauderdale, Florida 33306, United States; Not yet recruiting

Forest Investigative Site 039, Hollywood, Florida 33021, United States; Recruiting

Forest Investigative Site 041, Tampa, Florida 33603, United States; Recruiting

Forest Investigative Site 046, Brooksville, Florida 34613, United States; Recruiting

Forest Investigative Site 029, Atlanta, Georgia 30338, United States; Recruiting

Forest Investigative Site 025, Chicago, Illinois 60607, United States; Recruiting

Forest Investigative Site 037, Auburn, Maine 04210, United States; Recruiting

Forest Investigative Site 003, Oxon Hill, Maryland 20745, United States; Recruiting

Forest Investigative Site 042, Reisterstown, Maryland 21136, United States; Recruiting

Forest Investigative Site 023, Brockton, Massachusetts 02301, United States; Recruiting

Forest Investigative Site 040, St. Clair Shores, Michigan 48081, United States; Recruiting

Forest Investigative Site 006, Cary, North Carolina 27518, United States; Recruiting

Forest Investigative Site 017, Wilmington, North Carolina 28401, United States; Recruiting

Forest Investigative Site 022, Charlotte, North Carolina 28209, United States; Recruiting

Forest Investigative Site 007, Cincinnati, Ohio 45219, United States; Recruiting

Forest Investigative Site 033, Eugene, Oregon 97404, United States; Recruiting

Forest Investigative Site 004, Greenville, South Carolina 29615, United States; Recruiting

Forest Investigative Site 031, Mt Pleasant, South Carolina 29464, United States; Recruiting

Forest Investigative Site 018, Cleveland, Tennessee 37312, United States; Recruiting

Forest Investigative Site 032, Nashville, Tennessee 37203, United States; Recruiting

Forest Investigative Site 008, Corpus Christi, Texas 78404, United States; Recruiting

Starting date: August 2008
Last updated: September 1, 2009