Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2015 by University of Colorado, Boulder

Sponsor:

Collaborator:

Forest Laboratories

Information provided by (Responsible Party):

Christopher DeSouza, University of Colorado, Boulder

ClinicalTrials.gov Identifier:

NCT01595516

First received: March 5, 2012

Last updated: November 30, 2015

Last verified: November 2015

History of Changes

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.

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 Endothelial Regulation of Fibrinolysis

Resource links provided by NLM:

Drug Information available for: Metoprolol Metoprolol tartrate Metoprolol fumarate Metoprolol succinate Nebivolol Nebivolol Hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

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). ] [ Designated as safety issue: No ]
t-PA release is measured in response the bradykinin, sodium nitroprusside, vitamin C and bradykinin+vitamin C


Estimated Enrollment:	54
Study Start Date:	February 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (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

Eligibility


Ages Eligible for Study:	45 Years to 65 Years (Adult)
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 >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.

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: NCT01595516

Contacts


Contact: Jared 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
Contact 303-735-3056
Principal Investigator: Christopher DeSouza, Ph.D.

Sponsors and Collaborators

University of Colorado, Boulder

Forest Laboratories

Investigators


Principal Investigator:	Christopher DeSouza, Ph.D.	University of Colorado at Boulder

More Information


Responsible Party:	Christopher DeSouza, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier:	NCT01595516 History of Changes
Other Study ID Numbers:	BYS-MD-72
Study First Received:	March 5, 2012
Last Updated:	November 30, 2015
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016

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