Clinical trial NCT00770861: A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients
Official title: A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled, Dose-Titration Study of Nebivolol Monotherapy in Hispanic Patients With Stage 1 or Stage 2 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: nebivolol
Bystolic ™
Hypertension
Hispanic
Hypertension in Hispanic patients
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients 18 to 80 years of age, self-identified as Hispanic or Latino ethnicity
* 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:

* Secondary hypertension
* Are taking three or more antihypertensive agents
* Have uncontrolled or poorly controlled diabetes mellitus type I or type II
* Evidence of other concurrent disease or conditions that might interfere with the conduct of the study
* Participation in any investigational study within 30 days of Screening (Visit 1).
* Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use

Primary outcomes:
measure: Change From Baseline in Trough Seated DBP at Week 8(LOCF).
timeFrame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)
Secondary outcomes:
measure: Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).
timeFrame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: Forest Investigative Site
state: California
city: Chino
country: United States
facility: Forest Investigative Site
state: California
city: Long Beach
country: United States
facility: Forest Investigative Site
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site
state: California
city: National City
country: United States
facility: Forest Investigative Site
state: California
city: San Bernardino
country: United States
facility: Forest Investigative Site
state: California
city: Temecula
country: United States
facility: Forest Investigative Site
state: California
city: Tustin
country: United States
facility: Forest Investigative Site
state: California
city: Coral Gables
country: United States
facility: Forest Investigative Site
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site FL2
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site
state: Florida
city: Kissimmee
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: Pembroke Pines
country: United States
facility: Forest Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site
state: Georgia
city: Bronx
country: United States
facility: Forest Investigative Site
state: New York
city: New Windsor
country: United States
facility: Forest Investigative Site
state: New York
city: Carrollton
country: United States
facility: Forest Investigative Site
state: Texas
city: Corpus Christi
country: United States
facility: Forest Investigative Site
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site
state: Texas
city: El Paso
country: United States
facility: Forest Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: Ponce
country: Puerto Rico
facility: Forest Investigative Site
city: Salinas
country: Puerto Rico
facility: Forest Investigative Site
city: Santurce
country: Puerto Rico
facility: Forest Investigative Site
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories Inc.
name: Tatjana Lukic, MD., M.Sc.
role: STUDY_DIRECTOR
References: