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CompletedNCT01041287Updated Dec 19, 2014Results posted

Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells

A Phase 4 interventional study of Nebivolol and Metoprolol succinate in Hypertension, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-19.

Sponsored by Emory University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 96 is close to the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Emory University is the lead sponsor of 1,405 studies on the registry; 233 are open to participants now.

Of its 233 completed or terminated interventional studies of FDA-regulated products, 176 (76%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
96 participants (actual)

Study arms

  • Active comparator
    Nebivolol/ Metoprolol

    Subjects were randomized to nebivolol for 3 months. They "crossed over" to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained \>125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained \>125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained \>125/80, and further increased to 200 mg after 2 weeks if BP remained \>125/80.

    Drug: Nebivolol · Drug: Metoprolol succinate

  • Active comparator
    Metoprolol/Nebivolol

    Subjects were randomized to metoprolol succinate for 3 months. They "crossed over" to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained \>125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained \>125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained \>125/80, and further increased to 200 mg after 2 weeks if BP remained \>125/80.

    Drug: Nebivolol · Drug: Metoprolol succinate

Interventions

  • DrugNebivolol

    Nebivolol 5 mg PO qday for 2 weeks, titrated up to Nebivolol 10 mg PO qday if BP is \>125/80 for the 2 more weeks, and then titrated up to Nebivolol 20 mg PO qday if BP is \>125/80 for the remaining 8 weeks

    Also known as: Bystolic

  • DrugMetoprolol succinate

    Metoprolol 50 mg PO qday for 2 weeks, titrated up to Metoprolol 100 mg PO qday if BP is \>125/80 for the 2 more weeks, and then titrated up to Metoprolol 200 mg PO qday if BP is \>125/80 for the remaining 8 weeks

    Also known as: Toprol XL

06

What researchers measure

Primary outcomes

  1. Pulse Wave Velocity (Measure of Arterial Stiffness)

    The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).

    Time frame: Baseline

  2. Pulse Wave Velocity (Measure of Arterial Stiffness)

    The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).

    Time frame: 3 months

  3. Pulse Wave Velocity (Measure of Arterial Stiffness)

    The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).

    Time frame: 6 months

07

Results

Posted Dec 19, 2014

Participant flow

Patients recruited from clinic sites at Emory University Hospital and by advertisements between December 2009 through April 2012.

Treatment Period 1 (3 Months)
Participant flow — Treatment Period 1 (3 Months)
MilestoneNebivolol/ MetoprololMetoprolol/Nebivolol
Started1919
Completed1919
Not completed00
Treatment Period 2 (3 Months)
Participant flow — Treatment Period 2 (3 Months)
MilestoneNebivolol/ MetoprololMetoprolol/Nebivolol
Started1919
Completed1614
Not completed35
Withdrew: Lost to follow-up33
Withdrew: Adverse event02

Outcome measures

PrimaryPulse Wave Velocity (Measure of Arterial Stiffness)

The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).

Time frame:
Baseline
Reported as:
Mean · meters per second (m/s)
Pulse Wave Velocity (Measure of Arterial Stiffness)
meters per second (m/s)Nebivolol/ MetoprololMetoprolol/Nebivolol
Pulse Wave Velocity (Measure of Arterial Stiffness)9.4 ± 2.68.9 ± 1.5
PrimaryPulse Wave Velocity (Measure of Arterial Stiffness)

The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).

Time frame:
3 months
Reported as:
Mean · meters per second (m/s)
Pulse Wave Velocity (Measure of Arterial Stiffness)
meters per second (m/s)Nebivolol/ MetoprololMetoprolol/Nebivolol
Pulse Wave Velocity (Measure of Arterial Stiffness)8.4 ± 2.410.1 ± 1.4
PrimaryPulse Wave Velocity (Measure of Arterial Stiffness)

The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).

Time frame:
6 months
Reported as:
Mean · meters per second (m/s)
Pulse Wave Velocity (Measure of Arterial Stiffness)
meters per second (m/s)Nebivolol/ MetoprololMetoprolol/Nebivolol
Pulse Wave Velocity (Measure of Arterial Stiffness)9.1 ± 2.29.8 ± 1.6

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nebivolol/ Metoprolol—0/19 (0%)0/19 (0%)
Metoprolol/Nebivolol—2/19 (10.5%)0/19 (0%)
Most frequent serious events
Most frequent serious events
EventNebivolol/ MetoprololMetoprolol/Nebivolol
StrokeCardiac disorders0/192/19

Baseline characteristics

The population analysis for baseline characteristics are from subjects that completed both treatment periods.

Age, Categorical
Age, Categorical(Participants)Nebivolol/ MetoprololMetoprolol/NebivololTotal
<=18 years000
Between 18 and 65 years161228
>=65 years022
Sex: Female, Male
Sex: Female, Male(Participants)Nebivolol/ MetoprololMetoprolol/NebivololTotal
Female8513
Male8917
08

Study locations

1 site
  • Emory University
    Atlanta, Georgia 30322, United States
09

References and documents

Publications

  • Hayek SS, Poole JC, Neuman R, Morris AA, Khayata M, Kavtaradze N, Topel ML, Binongo JG, Li Q, Jones DP, Waller EK, Quyyumi AA. Differential effects of nebivolol and metoprolol on arterial stiffness, circulating progenitor cells, and oxidative stress. J Am Soc Hypertens. 2015 Mar;9(3):206-13. doi: 10.1016/j.jash.2014.12.013. Epub 2014 Dec 31. PubMed 25681236 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01041287
Lead sponsor
Emory University
Collaborators
Forest Laboratories
Responsible party
Arshed A. Quyyumi (Professor, Emory University) — Principal investigator
First posted
Dec 31, 2009
Start date
Dec 2009
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Dec 19, 2014
Last update
Dec 19, 2014

Study contacts

Arshed Quyyumi, MD
principal investigator · Emory University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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