Clinical trial NCT01057251: Nebivolol in Patients With Systolic Stage 2 Hypertension
Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of 5 mg or 20 mg Nebivolol Once Daily on Blood Pressure in Patients With Systolic Stage 2 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Nebivolol
Bystolic TM
Hypertension
Stage 2 Hypertension
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.


Eligibility criteria: Inclusion Criteria:

* male of female, 18 to 64 years of age at screening
* mean seated heart rate at least 60 bpm
* diagnosed systolic stage 2 hypertension
* unremarkable physical exam findings

Exclusion Criteria:

* high risk due to secondary hypertension or former stage 3 hypertension by JNC6
* concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
* currently taking medication that cannot be stopped during the course of the study
* participating other clinical trials
* member of the study center personnel
* documented drug abuse
* contra indication to beta blocker
* abnormal lab finding
* poor compliance
* other conditions judged by investigator that is not suitable for the study

Primary outcomes:
measure: Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
timeFrame: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)
measure: Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
timeFrame: Change from Baseline (Week 0) to Visit 4 (Week 6)
Secondary outcomes:
Other outcomes:
Locations:
city: Foley
country: United States
facility: Forest Investigative Site 008
state: Alabama
city: Montgomery
country: United States
facility: Forest Investigative Site 021
state: Alabama
city: Chino
country: United States
facility: Forest Investigative Site 006
state: California
city: Long Beach
country: United States
facility: Forest Investigative Site 002
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 004
state: California
city: Temecula
country: United States
facility: Forest Investigative Site 020
state: California
city: Coral Gables
country: United States
facility: Forest Investigative Site 028
state: Florida
city: Daytona Beach
country: United States
facility: Forest Investigative Site 014
state: Florida
city: Fort Lauderdale
country: United States
facility: Forest Investigative Site 037
state: Florida
city: Ft. Lauderdale
country: United States
facility: Forest Investigative Site 001
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site 033
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 026
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 017
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 010
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 030
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 009
state: Georgia
city: Augusta
country: United States
facility: Forest Investigative Site 031
state: Georgia
city: Meridian
country: United States
facility: Forest Investigative Site 039
state: Idaho
city: Auburn
country: United States
facility: Forest Investigative Site 007
state: Maine
city: Baltimore
country: United States
facility: Forest Investigative Site 038
state: Maryland
city: Baltimore
country: United States
facility: Forest Investigative Site 011
state: Maryland
city: Prince Frederick
country: United States
facility: Forest Investigative Site 029
state: Maryland
city: Paw Paw
country: United States
facility: Forest Investigative Site 023
state: Michigan
city: Florissant
country: United States
facility: Forest Investigative Site 005
state: Missouri
city: Las Vegas
country: United States
facility: Forest Investigative Site 041
state: Nevada
city: New York
country: United States
facility: Forest Investigative Site 040
state: New York
city: Hickory
country: United States
facility: Forest Investigative Site 012
state: North Carolina
city: Salisbury
country: United States
facility: Forest Investigative Site 027
state: North Carolina
city: Harleysville
country: United States
facility: Forest Investigative Site 024
state: Pennsylvania
city: Charleston
country: United States
facility: Forest Investigative Site 013
state: South Carolina
city: Greenville
country: United States
facility: Forest Investigative Site 035
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Forest Investigative Site 018
state: South Carolina
city: Simpsonville
country: United States
facility: Forest Investigative Site 022
state: South Carolina
city: Memphis
country: United States
facility: Forest Investigative Site 003
state: Tennessee
city: Corpus Christi
country: United States
facility: Forest Investigative Site 032
state: Texas
city: Richmond
country: United States
facility: Forest Investigative Site 025
state: Virginia
Study officials:
affiliation: Forest Research Institute, a Subsidiary of Forest Laboratories Inc.
name: Manfred Stapff, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Lewin A, Punzi H, Luo X, Stapff M. Nebivolol monotherapy for patients with systolic stage II hypertension: results of a randomized, placebo-controlled trial. Clin Ther. 2013 Feb;35(2):142-52. doi: 10.1016/j.clinthera.2012.12.015. Epub 2013 Jan 15.