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

This study is currently recruiting participants.
Verified May 2012 by University of Colorado, Boulder
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
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
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nebivolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on April 17, 2014