A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy
A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy
1 other identifier
interventional
207
1 country
26
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.
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
26 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
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedResults Posted
Study results publicly available
September 15, 2010
CompletedSeptember 15, 2010
August 1, 2010
9 months
November 3, 2008
August 19, 2010
August 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough Sitting Diastolic Blood Pressure
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.
From baseline, week 0 (Visit 9) to week 4 (Visit 12)
Secondary Outcomes (1)
Trough Sitting Systolic Blood Pressure
From baseline, week 0 (Visit 9) to week 4 (Visit 12)
Study Arms (2)
1
ACTIVE COMPARATORNebivolol 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
2
PLACEBO COMPARATORMatching placebo tablets, oral administration
Interventions
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 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Forest Investigative Site
Chandler, Arizona, 85225, United States
Forest Investigative Site
Phoenix, Arizona, 85050, United States
Forest Investigative Site
Los Angeles, California, 90057, United States
Forest Investigative Site
Bradenton, Florida, 34203, United States
Forest Investigative Site
Brooksville, Florida, 34613, United States
Forest Investigative Site
DeLand, Florida, 32720, United States
Forest Investigative Site
Hollywood, Florida, 33021, United States
Forest Investigative Site
Miami, Florida, 33014, United States
Forest Investigative Site
Miami, Florida, 33156, United States
Forest Investigative Site
Miami, Florida, 33169, United States
Forest Investigative Site
Pembroke Pines, Florida, 33024, United States
Forest Investigative Site
St. Petersburg, Florida, 33709, United States
Forest Investigative Site
Auburn, Maine, 04210, United States
Forest Investigative Site
Cary, North Carolina, 27518, United States
Forest Investigative Site
Hickory, North Carolina, 28601, United States
Forest Investigative Site
Salisbury, North Carolina, 28144, United States
Forest Investigative Site
Wilmington, North Carolina, 28401, United States
Forest Investigative Site
Winston-Salem, North Carolina, 27103, United States
Forest Investigative Site
Cincinnati, Ohio, 45242, United States
Forest Investigative Site
Marion, Ohio, 43302, United States
Forest Investigative Site
Lancaster, Pennsylvania, 17601, United States
Forest Investigative Site
Mt. Pleasant, South Carolina, 29464, United States
Forest Investigative Site
Simpsonville, South Carolina, 29681, United States
Forest Investigative Site
New Tazewell, Tennessee, 37825, United States
Forest Investigative Site
Dallas, Texas, 75231, United States
Forest Investigative Site
Dallas, Texas, 75234, United States
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, MSc
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
November 3, 2008
First Posted
November 5, 2008
Study Start
November 1, 2008
Primary Completion
August 1, 2009
Last Updated
September 15, 2010
Results First Posted
September 15, 2010
Record last verified: 2010-08