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

December 21, 2010 updated by: Forest Laboratories

A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled, Dose-Titration Study of Nebivolol Monotherapy in Hispanic Patients With Stage 1 or Stage 2 Hypertension

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Forest Investigative Site
      • Salinas, Puerto Rico, 00751
        • Forest Investigative Site
      • Santurce, Puerto Rico, 00909
        • Forest Investigative Site
  • United States
    • California
      • 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
        • Forest Investigative Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Forest Investigative Site
      • Hialeah, Florida, United States, 33012
        • Forest Investigative Site FL2
      • Hialeah, Florida, United States, 33012
        • Forest Investigative Site
      • Hialeah, Florida, United States, 33016
        • 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, 33024
        • Forest Investigative Site
      • Pembroke Pines, Florida, United States, 33027
        • Forest Investigative Site
      • West Palm Beach, Florida, United States, 33401
        • Forest Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • Forest Investigative Site
      • Atlanta, Georgia, United States, 30338
        • Forest Investigative Site
    • New York
      • Bronx, New York, United States, 10451
        • Forest Investigative Site
      • New Windsor, New York, United States, 12553
        • Forest Investigative Site
    • Texas
      • 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
        • Forest Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo tablets, oral administration
Drug: Placebo
Matching placebo tablets, oral administration
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 Names:
  • Bystolic (TM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Tatjana Lukic, MD., M.Sc., Forest Research Institute, a subsidiary of Forest Laboratories Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

October 9, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (Estimate)

October 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 26, 2011

Last Update Submitted That Met QC Criteria

December 21, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEB-MD-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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