Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01595516
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : October 26, 2017
Forest Laboratories
Information provided by (Responsible Party):
Christopher DeSouza, University of Colorado, Boulder

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.

Condition or disease Intervention/treatment Phase
Prehypertension Hypertension Drug: Nebivolol Drug: Metoprolol Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Nebivolol and Endothelial Regulation of Fibrinolysis
Study Start Date : February 2012
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Changes 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). ]
    t-PA release is measured in response the bradykinin, sodium nitroprusside, vitamin C and bradykinin+vitamin C

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01595516

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christopher DeSouza, Professor, University of Colorado, Boulder Identifier: NCT01595516     History of Changes
Other Study ID Numbers: BYS-MD-72
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
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
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists