Clinical trial NCT00785512: A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy
Official title: A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: nebivolol
Bystolic®
Hypertension
blood pressure
withdrawal
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.


Eligibility criteria: Inclusion Criteria:

* male and female outpatients 18 to 79 years of age
* Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
* meet criteria for stage I or II hypertension
* currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion Criteria:

* type 1 or type 2 diabetes
* secondary hypertension
* evidence of other concurrent disease or conditions that might interfere with the conduct of the study
* treatment with any investigational study drug within 30 days of Screening (Visit 1)
* have a history of hypersensitivity to nebivolol or other β-blockers

Primary outcomes:
measure: Trough Sitting Diastolic Blood Pressure
timeFrame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)
Secondary outcomes:
measure: Trough Sitting Systolic Blood Pressure
timeFrame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Forest Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site
state: Arizona
city: Los Angeles
country: United States
facility: Forest Investigative Site
state: California
city: Bradenton
country: United States
facility: Forest Investigative Site
state: Florida
city: Brooksville
country: United States
facility: Forest Investigative Site
state: Florida
city: DeLand
country: United States
facility: Forest Investigative Site
state: Florida
city: Hollywood
country: United States
facility: Forest Investigative Site
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site
state: Florida
city: St. Petersburg
country: United States
facility: Forest Investigative Site
state: Florida
city: Auburn
country: United States
facility: Forest Investigative Site
state: Maine
city: Cary
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Hickory
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Salisbury
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Wilmington
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Marion
country: United States
facility: Forest Investigative Site
state: Ohio
city: Lancaster
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Simpsonville
country: United States
facility: Forest Investigative Site
state: South Carolina
city: New Tazewell
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site
state: Texas
Study officials:
affiliation: Forest Research Institute, a Subsidiary of Forest Laboratories Inc.
name: Tatjana Lukic, MD, MSc
role: STUDY_DIRECTOR
References: