Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

March 18, 2013 updated by: Forest Laboratories

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
641

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Forest Investigative Site 065
      • Phoenix, Arizona, United States, 85014
        • Forest Investigative Site 067
      • Phoenix, Arizona, United States, 85014
        • Forest Investigative Site 070
    • California
      • Buena Park, California, United States, 90620
        • Forest Investigative Site 049
      • Burbank, California, United States, 91505
        • Forest Investigative Site 034
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 039
      • Fountain Valley, California, United States, 92708
        • Forest Investigative Site 024
      • Fresno, California, United States, 93726
        • Forest Investigative Site 020
      • Fresno, California, United States, 93726
        • Forest Investigative Site 021
      • Greenbrae, California, United States, 94904
        • Forest Investigative Site 040
      • La Mesa, California, United States, 91942
        • Forest Investigative Site 047
      • Los Angeles, California, United States, 90057
        • Forest Investigative Site 073
      • Roseville, California, United States, 95661
        • Forest Investigative Site 077
      • San Bernardino, California, United States, 92404
        • Forest Investigative Site 060
      • San Francisco, California, United States, 94115
        • Forest Investigative Site 054
      • Spring Valley, California, United States, 91978
        • Forest Investigative Site 018
    • Colorado
      • Denver, Colorado, United States, 80220
        • Forest Investigative Site 028
    • Florida
      • Brooksville, Florida, United States, 34601
        • Forest Investigative Site 059
      • Ft. Lauderdale, Florida, United States, 33306
        • Forest Investigative Site 033
      • Hallandale Beach, Florida, United States, 33009
        • Forest Investigative Site 006
      • Longwood, Florida, United States, 32779
        • Forest Investigative Site 044
      • Miami, Florida, United States, 33014
        • Forest Investigative Site 001
      • Miami, Florida, United States, 33014
        • Forest Investigative Site 012
      • Miami, Florida, United States, 33014
        • Forest Investigative Site 032
      • Miami, Florida, United States, 33014
        • Forest Investigative Site 055
      • Oviedo, Florida, United States, 32765
        • Forest Investigative Site 045
      • St. Petersburg, Florida, United States, 33709
        • Forest Investigative Site 031
    • Georgia
      • Atlanta, Georgia, United States, 30084
        • Forest Investigative Site 009
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Forest Investigative Site 007
      • Morton, Illinois, United States, 61550
        • Forest Investigative Site 004
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Forest Investigative Site 072
      • Newburgh, Indiana, United States, 47630
        • Forest Investigative Site 069
    • Kansas
      • Augusta, Kansas, United States, 67010
        • Forest Investigative Site 025
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Forest Investigative Site 029
      • Madisonville, Kentucky, United States, 42431
        • Forest Investigative Site 068
    • Louisiana
      • Metairie, Louisiana, United States, 70005
        • Forest Investigative Site 061
      • New Orleans, Louisiana, United States, 70119
        • Forest Investigative Site 057
      • New Orleans, Louisiana, United States, 70119
        • Forest Investigative Site 058
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Forest Investigative Site 008
    • Massachusetts
      • Fall River, Massachusetts, United States, 02702
        • Forest Investigative Site 062
    • Michigan
      • Paw Paw, Michigan, United States, 49079
        • Forest Investigative Site 075
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Forest Investigative Site 019
      • Chaska, Minnesota, United States, 55318
        • Forest Investigative Site 017
    • Mississippi
      • Belzoni, Mississippi, United States, 39038
        • Forest Investigative Site 038
      • Olive Branch, Mississippi, United States, 38654
        • Forest Investigative Site 035
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Forest Investigative Site 023
      • Las Vegas, Nevada, United States, 89101
        • Forest Investigative Site 048
      • Las Vegas, Nevada, United States, 89101
        • Forest Investigative Site 052
    • New Jersey
      • Elizabeth, New Jersey, United States, 27609
        • Forest Investigative Site 014
      • Trenton, New Jersey, United States, 08611
        • Forest Investigative Site 051
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Forest Investigative Site 003
      • Charlotte, North Carolina, United States, 28277
        • Forest Investigative Site 010
      • Raleigh, North Carolina, United States, 27609
        • Forest Investigative Site 011
      • Raleigh, North Carolina, United States, 27609
        • Forest Investigative Site 016
      • Wilmington, North Carolina, United States, 28401
        • Forest Investigative Site 005
      • Winston-Salem, North Carolina, United States, 27103
        • Forest Investigative Site 036
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Forest Investigative Site 002
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Forest Investigative Site 050
    • Oregon
      • Portland, Oregon, United States, 33709
        • Forest Investigative Site 030
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
        • Forest Investigative Site 056
    • South Carolina
      • Pelzer, South Carolina, United States, 29669
        • Forest Investigative Site 022
    • Texas
      • Beaumont, Texas, United States, 77701
        • Forest Investigative Site 053
      • Boerne, Texas, United States, 78006
        • Forest Investigative Site 066
      • Corpus Christi, Texas, United States, 78404
        • Forest Investigative Site 076
      • Dallas, Texas, United States, 75234
        • Forest Investigative Site 037
      • Haltom City, Texas, United States, 84070
        • Forest Investigative Site 043
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 026
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 027
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 015
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 074
    • Utah
      • Orem, Utah, United States, 84058
        • Forest Investigative Site 071
      • Sandy, Utah, United States, 84070
        • Forest Investigative Site 042
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Forest Investigative Site 063
      • Norfolk, Virginia, United States, 23502
        • Forest Investigative Site 064
    • Washington
      • Port Orchard, Washington, United States, 98366
        • Forest Investigative Site 046

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female outpatients, of age 18 - 54 years
  • Patients diagnosed with stage 1 or stage 2 essential hypertension
  • Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

  • Secondary hypertension or severe hypertension
  • History of Type 1 diabetes mellitus
  • A medical contraindication to discontinuing a current antihypertensive therapy
  • Clinically significant respiratory disease that prohibit use of a beta blocker

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Drug: Nebivolol
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Placebo Comparator: 2
Dose-matched placebo
Drug: Placebo
Dose-match placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Trough Seated Diastolic Blood Pressure (DBP)
Time Frame: Change from Baseline to Week 8
Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Change from Baseline to Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trough Seated Systolic Blood Pressure (SBP)
Time Frame: Change from Baseline to Week 8
Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Change from Baseline to Week 8

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Forest Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tatjana Lukic, MD, M. Sc., Forest Laboratories

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEB-MD-28

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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