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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01415531
First received: August 10, 2011
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Trough Seated Diastolic Blood Pressure (DBP) [ Time Frame: Change from Baseline to Week 8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Trough Seated Systolic Blood Pressure (SBP) [ Time Frame: Change from Baseline to Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 641
Study Start Date: August 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415531

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

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01415531     History of Changes
Other Study ID Numbers: NEB-MD-28
Study First Received: August 10, 2011
Results First Received: March 18, 2013
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Stage 1
Stage 2
Hypertension

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

ClinicalTrials.gov processed this record on October 29, 2014