Clinical trial NCT01415531: Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Stage 1
Stage 2
Hypertension
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 641
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients, of age 18 - 54 years
* Patients diagnosed with stage 1 or stage 2 essential hypertension
* Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

* Secondary hypertension or severe hypertension
* History of Type 1 diabetes mellitus
* A medical contraindication to discontinuing a current antihypertensive therapy
* Clinically significant respiratory disease that prohibit use of a beta blocker

Primary outcomes:
measure: Trough Seated Diastolic Blood Pressure (DBP)
timeFrame: Change from Baseline to Week 8
Secondary outcomes:
measure: Trough Seated Systolic Blood Pressure (SBP)
timeFrame: Change from Baseline to Week 8
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Forest Investigative Site 065
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 067
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 070
state: Arizona
city: Buena Park
country: United States
facility: Forest Investigative Site 049
state: California
city: Burbank
country: United States
facility: Forest Investigative Site 034
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 039
state: California
city: Fountain Valley
country: United States
facility: Forest Investigative Site 024
state: California
city: Fresno
country: United States
facility: Forest Investigative Site 020
state: California
city: Fresno
country: United States
facility: Forest Investigative Site 021
state: California
city: Greenbrae
country: United States
facility: Forest Investigative Site 040
state: California
city: La Mesa
country: United States
facility: Forest Investigative Site 047
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 073
state: California
city: Roseville
country: United States
facility: Forest Investigative Site 077
state: California
city: San Bernardino
country: United States
facility: Forest Investigative Site 060
state: California
city: San Francisco
country: United States
facility: Forest Investigative Site 054
state: California
city: Spring Valley
country: United States
facility: Forest Investigative Site 018
state: California
city: Denver
country: United States
facility: Forest Investigative Site 028
state: Colorado
city: Brooksville
country: United States
facility: Forest Investigative Site 059
state: Florida
city: Ft. Lauderdale
country: United States
facility: Forest Investigative Site 033
state: Florida
city: Hallandale Beach
country: United States
facility: Forest Investigative Site 006
state: Florida
city: Longwood
country: United States
facility: Forest Investigative Site 044
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 001
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 012
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 032
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 055
state: Florida
city: Oviedo
country: United States
facility: Forest Investigative Site 045
state: Florida
city: St. Petersburg
country: United States
facility: Forest Investigative Site 031
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 009
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site 007
state: Illinois
city: Morton
country: United States
facility: Forest Investigative Site 004
state: Illinois
city: Evansville
country: United States
facility: Forest Investigative Site 072
state: Indiana
city: Newburgh
country: United States
facility: Forest Investigative Site 069
state: Indiana
city: Augusta
country: United States
facility: Forest Investigative Site 025
state: Kansas
city: Louisville
country: United States
facility: Forest Investigative Site 029
state: Kentucky
city: Madisonville
country: United States
facility: Forest Investigative Site 068
state: Kentucky
city: Metairie
country: United States
facility: Forest Investigative Site 061
state: Louisiana
city: New Orleans
country: United States
facility: Forest Investigative Site 057
state: Louisiana
city: New Orleans
country: United States
facility: Forest Investigative Site 058
state: Louisiana
city: Lutherville
country: United States
facility: Forest Investigative Site 008
state: Maryland
city: Fall River
country: United States
facility: Forest Investigative Site 062
state: Massachusetts
city: Paw Paw
country: United States
facility: Forest Investigative Site 075
state: Michigan
city: Brooklyn Center
country: United States
facility: Forest Investigative Site 019
state: Minnesota
city: Chaska
country: United States
facility: Forest Investigative Site 017
state: Minnesota
city: Belzoni
country: United States
facility: Forest Investigative Site 038
state: Mississippi
city: Olive Branch
country: United States
facility: Forest Investigative Site 035
state: Mississippi
city: Las Vegas
country: United States
facility: Forest Investigative Site 023
state: Nevada
city: Las Vegas
country: United States
facility: Forest Investigative Site 048
state: Nevada
city: Las Vegas
country: United States
facility: Forest Investigative Site 052
state: Nevada
city: Elizabeth
country: United States
facility: Forest Investigative Site 014
state: New Jersey
city: Trenton
country: United States
facility: Forest Investigative Site 051
state: New Jersey
city: Asheboro
country: United States
facility: Forest Investigative Site 003
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 010
state: North Carolina
city: Raleigh
country: United States
facility: Forest Investigative Site 011
state: North Carolina
city: Raleigh
country: United States
facility: Forest Investigative Site 016
state: North Carolina
city: Wilmington
country: United States
facility: Forest Investigative Site 005
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site 036
state: North Carolina
city: Columbus
country: United States
facility: Forest Investigative Site 002
state: Ohio
city: Norman
country: United States
facility: Forest Investigative Site 050
state: Oklahoma
city: Portland
country: United States
facility: Forest Investigative Site 030
state: Oregon
city: Downingtown
country: United States
facility: Forest Investigative Site 056
state: Pennsylvania
city: Pelzer
country: United States
facility: Forest Investigative Site 022
state: South Carolina
city: Beaumont
country: United States
facility: Forest Investigative Site 053
state: Texas
city: Boerne
country: United States
facility: Forest Investigative Site 066
state: Texas
city: Corpus Christi
country: United States
facility: Forest Investigative Site 076
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 037
state: Texas
city: Haltom City
country: United States
facility: Forest Investigative Site 043
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 015
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 026
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 027
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 074
state: Texas
city: Orem
country: United States
facility: Forest Investigative Site 071
state: Utah
city: Sandy
country: United States
facility: Forest Investigative Site 042
state: Utah
city: Norfolk
country: United States
facility: Forest Investigative Site 063
state: Virginia
city: Norfolk
country: United States
facility: Forest Investigative Site 064
state: Virginia
city: Port Orchard
country: United States
facility: Forest Investigative Site 046
state: Washington
Study officials:
affiliation: Forest Laboratories
name: Tatjana Lukic, MD, M. Sc.
role: STUDY_DIRECTOR
References: