Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)
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ClinicalTrials.gov Identifier: NCT01595516 |
Recruitment Status
:
Completed
First Posted
: May 10, 2012
Last Update Posted
: October 26, 2017
|
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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
|
- 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01595516
United States, Colorado | |
UC-Boulder Clinical and Translational Research Center | |
Boulder, Colorado, United States, 80309 |
Principal Investigator: | Christopher DeSouza, Ph.D. | University of Colorado at Boulder |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Christopher DeSouza, Professor, University of Colorado, Boulder |
ClinicalTrials.gov 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:
Prehypertension Vascular Diseases Cardiovascular Diseases Metoprolol Nebivolol Anti-Arrhythmia Agents 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 Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |