Clinical trial NCT00734630: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: nebivolol
Bystolic ™
lisinopril
losartan
Hypertension
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12
timeFrame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)
Secondary outcomes:
measure: Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12
timeFrame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)
Other outcomes:
Locations:
city: Gulf Shores
country: United States
facility: Forest Investigative Site 070
state: Alabama
city: Huntsville
country: United States
facility: Forest Investigative Site 092
state: Alabama
city: Mesa
country: United States
facility: Forest Investigative Site 058
state: Arizona
city: Tempe
country: United States
facility: Forest Investigative Site 059
state: Arizona
city: Anaheim
country: United States
facility: Forest Investigative Site 024
state: California
city: Bell Gardens
country: United States
facility: Forest Investigative Site 012
state: California
city: Chino
country: United States
facility: Forest Investigative Site 026
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 083
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 030
state: California
city: Orange
country: United States
facility: Forest Investigative Site 053
state: California
city: Riverside
country: United States
facility: Forest Investigative Site 077
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 034
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 028
state: California
city: San Bernardino
country: United States
facility: Forest Investigative Site 048
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 075
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 087
state: California
city: Temecula
country: United States
facility: Forest Investigative Site 090
state: California
city: Tustin
country: United States
facility: Forest Investigative Site 010
state: California
city: Westlake Village
country: United States
facility: Forest Investigative Site 001
state: California
city: Wheat Ridge
country: United States
facility: Forest Investigative Site 061
state: Colorado
city: Brooksville
country: United States
facility: Forest Investigative Site 046
state: Florida
city: Deland
country: United States
facility: Forest Investigative Site 015
state: Florida
city: Fort Lauderdale
country: United States
facility: Forest Investigative Site 035
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site 009
state: Florida
city: Hollywood
country: United States
facility: Forest Investigative Site 039
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 044
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 002
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 085
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 091
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 013
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 052
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 049
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 065
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 041
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 029
state: Georgia
city: Decatur
country: United States
facility: Forest Investigative Site 068
state: Georgia
city: Addison
country: United States
facility: Forest Investigative Site 050
state: Illinois
city: Chicago
country: United States
facility: Forest Investigative Site 025
state: Illinois
city: Chicago
country: United States
facility: Forest Investigative Site 057
state: Illinois
city: Joliet
country: United States
facility: Forest Investigative Site 076
state: Illinois
city: Orland Park
country: United States
facility: Forest Investigative Site 014
state: Illinois
city: Overland Park
country: United States
facility: Forest Investigative Site 079
state: Kansas
city: Auburn
country: United States
facility: Forest Investigative Site 037
state: Maine
city: Biddeford
country: United States
facility: Forest Investigative Site 045
state: Maine
city: Oxon Hill
country: United States
facility: Forest Investigative Site 003
state: Maryland
city: Prince Frederick
country: United States
facility: Forest Investigative Site 060
state: Maryland
city: Reisterstown
country: United States
facility: Forest Investigative Site 042
state: Maryland
city: Brockton
country: United States
facility: Forest Investigative Site 023
state: Massachusetts
city: Brockton
country: United States
facility: Forest Investigative Site 066
state: Massachusetts
city: St. Clair Shores
country: United States
facility: Forest Investigative Site 040
state: Michigan
city: Rolling Fork
country: United States
facility: Forest Investigative Site 067
state: Mississippi
city: Edison
country: United States
facility: Forest Investigative Site 051
state: New Jersey
city: New York
country: United States
facility: Forest Investigative Site 088
state: New York
city: Syracuse
country: United States
facility: Forest Investigative Site 086
state: New York
city: Cary
country: United States
facility: Forest Investigative Site 006
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 022
state: North Carolina
city: Harrisburg
country: United States
facility: Forest Investigative Site 064
state: North Carolina
city: Raleigh
country: United States
facility: Forest Investigative Site 071
state: North Carolina
city: Wilmington
country: United States
facility: Forest Investigative Site 017
state: North Carolina
city: Fargo
country: United States
facility: Forest Investigative Site 055
state: North Dakota
city: Cincinnati
country: United States
facility: Forest Investigative Site 007
state: Ohio
city: Cleveland
country: United States
facility: Forest Investigative Site 054
state: Ohio
city: Perrysburg
country: United States
facility: Forest Investigative Site 056
state: Ohio
city: Ashland
country: United States
facility: Forest Investigative Site 080
state: Oregon
city: Eugene
country: United States
facility: Forest Investigative Site 033
state: Oregon
city: Harleysville
country: United States
facility: Forest Investigative Site 081
state: Pennsylvania
city: Greenville
country: United States
facility: Forest Investigative Site 004
state: South Carolina
city: Mt Pleasant
country: United States
facility: Forest Investigative Site 031
state: South Carolina
city: Cleveland
country: United States
facility: Forest Investigative Site 018
state: Tennessee
city: Memphis
country: United States
facility: Forest Investigative Site 043
state: Tennessee
city: Nashville
country: United States
facility: Forest Investigative Site 032
state: Tennessee
city: Corpus Christi
country: United States
facility: Forest Investigative Site 008
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 063
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 062
state: Texas
city: Richmond
country: United States
facility: Forest Investigative Site 016
state: Virginia
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
name: Manfred Stapff, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Weiss RJ, Stapff M, Lin Y. Placebo effect and efficacy of nebivolol in patients with hypertension not controlled with lisinopril or losartan: a phase IV, randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2013 Apr;13(2):129-40. doi: 10.1007/s40256-013-0010-y.