Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

Overview[ - collapse ][ - ]

Purpose The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. The investigators further hypothesize that the improvement in the capacity of the vascular endothelium to release t-PA with nebivolol is mediated, in part, by the compound's antioxidant properties.
ConditionPrehypertension
Hypertension
InterventionDrug: Nebivolol
Drug: Metoprolol
Drug: Placebo
PhasePhase 4
SponsorUniversity of Colorado, Boulder
Responsible PartyUniversity of Colorado, Boulder
ClinicalTrials.gov IdentifierNCT01595516
First ReceivedMarch 5, 2012
Last UpdatedMay 8, 2012
Last verifiedMay 2012

Tracking Information[ + expand ][ + ]

First Received DateMarch 5, 2012
Last Updated DateMay 8, 2012
Start DateFebruary 2012
Estimated Primary Completion DateFebruary 2014
Current Primary Outcome MeasuresChanges from baseline in endothelial t-PA release [Time Frame: t-PA release 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]t-PA release is measured in response the bradykinin, sodium nitroprusside, vitamin C and bradykinin+vitamin C
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleNebivolol and Endothelial Regulation of Fibrinolysis (NERF)
Official TitleNebivolol and Endothelial Regulation of Fibrinolysis
Brief Summary
The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult
humans with elevated blood pressure to a greater extent than either metoprolol or placebo.
The investigators further hypothesize that the improvement in the capacity of the vascular
endothelium to release t-PA with nebivolol is mediated, in part, by the compound's
antioxidant properties.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Condition
  • Prehypertension
  • Hypertension
InterventionDrug: Nebivolol
5 mg tablet to be taken by mouth once per day for 12 weeks
Other Names:
BystolicDrug: Metoprolol
100 mg tablet to be taken by mouth once per day for 12 weeks
Other Names:
Toprol-XLDrug: Placebo
Gelatin capsule to be taken by mouth once per day for 12 weeks
Study Arm (s)
  • Active Comparator: Nebivolol
  • Active Comparator: Metoprolol
  • Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment54
Estimated Completion DateFebruary 2014
Estimated Primary Completion DateFebruary 2014
Eligibility 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 >125 mmHg and <160 mmHg and/or diastolic >80 mmHg and <100 mmHg.

- All of the women in the study will be postmenopausal and not receiving hormone
replacement therapy (HRT) currently or in the preceding 3-year period.

- 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 and 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 >160 mmHg or a seated
diastolic blood pressure >100 mmHg will be excluded.
GenderBoth
Ages45 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsContact: Jared Greiner, M.S.
303-735-4955
jared.greiner@colorado.edu
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01595516
Other Study ID NumbersBYS-MD-72
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of Colorado, Boulder
Study SponsorUniversity of Colorado, Boulder
CollaboratorsForest Laboratories
Investigators Principal Investigator: Christopher DeSouza, Ph.D. University of Colorado at Boulder
Verification DateMay 2012

Locations[ + expand ][ + ]

UC-Boulder Clinical and Translational Research Center
Boulder, Colorado, United States, 80309
| 303-735-3056
Principal Investigator: Christopher DeSouza, Ph.D.
Recruiting