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A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00770861
First received: October 9, 2008
Last updated: December 21, 2010
Last verified: December 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Hypertension
 Drug: Nebivolol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change From Baseline in Trough Seated DBP at Week 8(LOCF). [ Time Frame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF). [ Time Frame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8) ] [ Designated as safety issue: No ]
    The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.


Enrollment: 277
Study Start Date: September 2008
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nebivolol
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
 Drug: Nebivolol
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
Other Name: Bystolic (TM)
Placebo Comparator: Placebo
Matching placebo tablets, oral administration
 Drug: Placebo
Matching placebo tablets, oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770861

Locations
United States, California
Forest Investigative Site
Buena Park, California, United States, 90620
Forest Investigative Site
Chino, California, United States, 91710
Forest Investigative Site
Long Beach, California, United States, 90806
Forest Investigative Site
Los Angeles, California, United States, 90057
Forest Investigative Site
National City, California, United States, 91950
Forest Investigative Site
San Bernardino, California, United States, 92404
Forest Investigative Site
Temecula, California, United States, 92591
Forest Investigative Site
Tustin, California, United States, 92780
United States, Florida
Forest Investigative Site
Coral Gables, Florida, United States, 33134
Forest Investigative Site
Hialeah, Florida, United States, 33012
Forest Investigative Site
Hialeah, Florida, United States, 33016
Forest Investigative Site FL2
Hialeah, Florida, United States, 33012
Forest Investigative Site
Kissimmee, Florida, United States, 34741
Forest Investigative Site
Miami, Florida, United States, 33169
Forest Investigative Site
Miami, Florida, United States, 33014
Forest Investigative Site
Miami, Florida, United States, 33183
Forest Investigative Site
Pembroke Pines, Florida, United States, 33027
Forest Investigative Site
Pembroke Pines, Florida, United States, 33024
Forest Investigative Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Forest Investigative Site
Atlanta, Georgia, United States, 30312
Forest Investigative Site
Atlanta, Georgia, United States, 30338
United States, New York
Forest Investigative Site
Bronx, New York, United States, 10451
Forest Investigative Site
New Windsor, New York, United States, 12553
United States, Texas
Forest Investigative Site
Carrollton, Texas, United States, 75006
Forest Investigative Site
Corpus Christi, Texas, United States, 78404
Forest Investigative Site
Dallas, Texas, United States, 75235
Forest Investigative Site
El Paso, Texas, United States, 79902
Forest Investigative Site
San Antonio, Texas, United States, 78229
Forest Investigative Site
San Antonio, Texas, United States, 78224
Puerto Rico
Forest Investigative Site
Ponce, Puerto Rico, 00717
Forest Investigative Site
Salinas, Puerto Rico, 00751
Forest Investigative Site
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Tatjana Lukic, MD., M.Sc. Forest Research Institute, a subsidiary of Forest Laboratories Inc.
  More Information

No publications provided

Responsible Party: John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a Subsidiary of Forest Laboratories Inc.
ClinicalTrials.gov Identifier: NCT00770861     History of Changes
Other Study ID Numbers: NEB-MD-16
Study First Received: October 9, 2008
Results First Received: November 9, 2010
Last Updated: December 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
nebivolol
Bystolic ™
Hypertension
Hispanic
Hypertension in Hispanic patients

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nebivolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013