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Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nebivolol (Drug); Metoprolol succinate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Arshed Quyyumi, MD, Principal Investigator, Affiliation: Emory University


Hypertension, or high blood pressure, is a common disease that affects many Americans, and can lead to devastating consequences such as heart attack, stroke, and death if not treated. Nebivolol is a medication that has been recently approved by the FDA for the treatment of hypertension. Nebivolol has an unusual profile compared to other medications, in that its effects may be related to release of a substance called nitric oxide. Nitric oxide is released from the cells lining the blood vessels, and nebivolol may stimulate these cells to release more nitric oxide. Our study will investigate whether treatment with nebivolol, as compared to another medication called metoprolol, in hypertensive subjects will be more effective in protecting blood vessels against the harmful effects of high blood pressure. The mechanisms we will investigate include oxidative stress markers and circulating levels of endothelial progenitor cells.

Clinical Details

Official title: Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells in Subjects With Hypertension

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Pulse Wave Velocity (Measure of Arterial Stiffness)

Pulse Wave Velocity (Measure of Arterial Stiffness)

Pulse Wave Velocity (Measure of Arterial Stiffness)


Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria: 1. Males or post-menopausal females aged 21-80 years. 2. Hypertensive patients (BP >135/85) will be eligible to participate. 3. Patients on current anti-hypertensive therapy that does not include beta blockade should have BP >135/85. 4. Patients on anti-hypertensive therapy including beta blockade will have their beta blockers discontinued gradually over 2 weeks before enrolment. 5. Concomitant therapy: Patients will be allowed to be on comcomitant therapy with aspirin, statins, thiazide diuretics, calcium antagonists (for treatment of hypertension), clonidine, vasodilators, or angiotensin antagonists. Patients will be on stable medical therapy for at least 2 months before recruitment. Patients with previous treatment with beta adrenergic blockers (metoprolol, propranolol, atenolol, and labetalol) will also be eligible to participate, but will be randomized to the study beta blocker. Exclusion Criteria: 1. Age < 21 or >80 years 2. Initiation or change in dose of statin or anti-hypertensive therapy within 2 months before the study 3. Premenopausal females with potential for pregnancy 4. Acute infection in previous 2 weeks 5. History of substance abuse 6. Current neoplasm 7. Chronic renal failure [creatinine > 2. 5 mg/dL] or liver failure (Liver enzymes >2X normal) 8. Acute coronary syndrome, Class IV heart failure, CVA, coronary intervention within 2 months 9. Known aortic stenosis, hypertrophic cardiomyopathy. 10. Inability to give informed consent 11. Inability to return to Emory for follow-up testing

Locations and Contacts

Emory University, Atlanta, Georgia 30322, United States
Additional Information

Starting date: December 2009
Last updated: December 12, 2014

Page last updated: August 23, 2015

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