A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients
A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled, Dose-Titration Study of Nebivolol Monotherapy in Hispanic Patients With Stage 1 or Stage 2 Hypertension
1 other identifier
interventional
277
2 countries
32
Brief Summary
This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedResults Posted
Study results publicly available
January 26, 2011
CompletedJanuary 26, 2011
December 1, 2010
1.2 years
October 9, 2008
November 9, 2010
December 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Trough Seated DBP at Week 8(LOCF).
The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.
From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)
Secondary Outcomes (1)
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).
From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)
Study Arms (2)
Nebivolol
ACTIVE COMPARATORNebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
Placebo
PLACEBO COMPARATORMatching placebo tablets, oral administration
Interventions
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Forest Investigative Site
Buena Park, California, 90620, United States
Forest Investigative Site
Chino, California, 91710, United States
Forest Investigative Site
Long Beach, California, 90806, United States
Forest Investigative Site
Los Angeles, California, 90057, United States
Forest Investigative Site
National City, California, 91950, United States
Forest Investigative Site
San Bernardino, California, 92404, United States
Forest Investigative Site
Temecula, California, 92591, United States
Forest Investigative Site
Tustin, California, 92780, United States
Forest Investigative Site
Coral Gables, Florida, 33134, United States
Forest Investigative Site FL2
Hialeah, Florida, 33012, United States
Forest Investigative Site
Hialeah, Florida, 33012, United States
Forest Investigative Site
Hialeah, Florida, 33016, United States
Forest Investigative Site
Kissimmee, Florida, 34741, United States
Forest Investigative Site
Miami, Florida, 33014, United States
Forest Investigative Site
Miami, Florida, 33169, United States
Forest Investigative Site
Miami, Florida, 33183, United States
Forest Investigative Site
Pembroke Pines, Florida, 33024, United States
Forest Investigative Site
Pembroke Pines, Florida, 33027, United States
Forest Investigative Site
West Palm Beach, Florida, 33401, United States
Forest Investigative Site
Atlanta, Georgia, 30312, United States
Forest Investigative Site
Atlanta, Georgia, 30338, United States
Forest Investigative Site
New Windsor, New York, 12553, United States
Forest Investigative Site
The Bronx, New York, 10451, United States
Forest Investigative Site
Carrollton, Texas, 75006, United States
Forest Investigative Site
Corpus Christi, Texas, 78404, United States
Forest Investigative Site
Dallas, Texas, 75235, United States
Forest Investigative Site
El Paso, Texas, 79902, United States
Forest Investigative Site
San Antonio, Texas, 78224, United States
Forest Investigative Site
San Antonio, Texas, 78229, United States
Forest Investigative Site
Ponce, 00717, Puerto Rico
Forest Investigative Site
Salinas, 00751, Puerto Rico
Forest Investigative Site
Santurce, 00909, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Whalen, MD Executive Director of Clinical Development - Cardiovascular and Metabolism
- Organization
- Forest Laboratories
Study Officials
- STUDY DIRECTOR
Tatjana Lukic, MD., M.Sc.
Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 10, 2008
Study Start
September 1, 2008
Primary Completion
November 1, 2009
Last Updated
January 26, 2011
Results First Posted
January 26, 2011
Record last verified: 2010-12