Nebivolol and the Endothelin (ET)-1 System (NETS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Colorado, Boulder.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Christopher DeSouza, University of Colorado, Boulder
ClinicalTrials.gov Identifier:
NCT01395329
First received: June 9, 2011
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Nebivolol and the Endothelin (ET)-1 System

Resource links provided by NLM:


Further study details as provided by University of Colorado, Boulder:

Primary Outcome Measures:
  • ET-1-mediated vasoconstrictor tone [ Time Frame: Forearm blood flow will be measured at week 3 (before the 12 week drug or placebo intervention) and at week 15 (after the 12 week drug or placebo intervention). ] [ Designated as safety issue: No ]
    Forearm blood flow is measured in response to Acetylcholine, Sodium Nitroprusside, BQ-123, BQ-788 and Acetylcholine combined with BQ-123 and BQ-788


Estimated Enrollment: 48
Study Start Date: May 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nebivolol Drug: Nebivolol
5 mg tablet to be taken by mouth once per day for 12 weeks
Other Name: Bystolic
Active Comparator: Metoprolol Drug: Metoprolol
100 mg tablet to be taken by mouth once per day for 12 weeks
Other Name: Toprol-XL
Placebo Comparator: Placebo Drug: Placebo
gelatin capsule to be taken by mouth once per day for 12 weeks

Detailed Description:
  1. The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.
  2. The investigators further hypothesize that reducing ET-1 vasoconstrictor activity contributes to the improvement in endothelial vasodilator function associated with nebivolol.
  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.
  • Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure >130 mmHg and < 160 mm Hg and/or diastolic blood pressure >80 mmHg and < 100 mm Hg.
  • All of the women in the study will be postmenopausal (at least 1 year from last menstrual cycle) and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
  • Lastly, candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study.

Exclusion Criteria:

  • Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits)
  • Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication an aspirin) medications will not be eligible.
  • Fasting plasma glucose >126 mg/dL.
  • Potential candidates with a resting heart rate of < 50 beats/minute will be excluded.
  • Use of hormone replacement therapy.
  • In hypertensive subjects, a seated systolic blood pressure greater than 160 mmHg or a seated diastolic blood pressure greater than 100 mmHg.
  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: NCT01395329

Contacts
Contact: Jared J Greiner, M.S. 303-735-4955 jared.greiner@colorado.edu

Locations
United States, Colorado
UC-Boulder Clinical and Translational Research Center Recruiting
Boulder, Colorado, United States, 80309
Principal Investigator: Christopher A DeSouza, Ph.D.         
Sponsors and Collaborators
University of Colorado, Boulder
Forest Laboratories
Investigators
Principal Investigator: Christopher A DeSouza, Ph.D. University of Colorado at Boulder
  More Information

No publications provided

Responsible Party: Christopher DeSouza, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT01395329     History of Changes
Other Study ID Numbers: BYS-MD-57
Study First Received: June 9, 2011
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prehypertension
Hypertension
Cardiovascular Diseases
Vascular Diseases
Metoprolol
Metoprolol succinate
Nebivolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 22, 2014