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HypertensionPhase 4NEMENDASNCT01248338

Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function

A Phase 4 study testing metoprolol succinate and Nebivolol in people with Hypertension, run by Berlin-Chemie AG Menarini Group at 1 site in Estonia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An impairment of endothelial function plays the central role in the pathogenesis of cardiovascular diseases and their complications. Most of cardiovascular risk factors are known to impair endothelial function and the established disease further aggravates endothelial dysfunction. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Hypertension
What is being tested?
metoprolol succinate and Nebivolol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEstonia
Study dates
Mar 2006to Dec 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with mild to moderate essential hypertension (systolic BP 140-179 mmHg and/or diastolic BP 90-109 mmHg)*
  • Male and female patients aged 30-65 years Newly diagnosed untreated patients or previously diagnosed patients who were without treatment at least two weeks prior to screening* If patient has been taken previously antihypertensive medication the BP values are originated after untreated two weeks before randomization

Who cannot join

  • Concomitant medication: Cyclic antidepressants, MAO inhibitors, corticosteroids
  • Diabetes I or II type (fasting venous plasma glucose > 6.4 mmol/l)
  • Bronchial asthma and chronic obstructive airway disease
  • Body mass index > 30 kg/m2
  • Ischaemic heart disease (III, IV stage, Canadian Cardiovascular Society)
  • Clinically relevant heart failure (NYHA class II - IV)
Show all 23Show fewer
  • Clinically relevant valve disease (physical examination)
  • Arrhythmias and conduction disturbances, requiring therapy, sinus bradycardia at rest < 50 b/min, sick sinus syndrome, AV - block stage II - III
  • Secondary hypertension (urea >8.3 mmol/l, creatinine >120μmol/l (males), >103 μmol/l (females), TSH > 4.0mIU/l, free T4 > 27 pmol/l)
  • Clinically relevant atherosclerotic disease of lower extremities
  • Acute inflammation (according to CRP > 10mg/l)
  • Hypercholesterolemia (> 6,5 mmol/l)
  • Allergic reaction to beta-blockers
  • Pregnant or breast-feeding women
  • History of hepatic, renal, metabolic or endocrine diseases
  • Smoking > 10 cigarettes per day
  • Alcohol consumption > 7 drinks per week (drink = 0,33 l beer, 120 ml wine or 30 ml strong alcoholic drink)
  • The patient has had surgery or disease of the gastrointestinal tract which, in the opinion of the investigator, may influence the absorption or elimination of the study drug.
  • The patient has a severe organic disorder that may interfere with the absorption, pharmacokinetics, or elimination of the study medication.
  • The patient has a comorbid condition that would be expected to result in death during the trial period (e.g., terminal cancer, AIDS).
  • The patient has chronic psychoses or behavioural conditions that would limit the ability of the patient to comply with the requirements of this study.
  • The patient has known hypersensitivity to Nebivolol, Metoprolol or hydrochlorothiazide related compounds.
  • Patient is enrolled in another clinical trial.

Trial locations and contacts

1 site in 1 country.

Estonia1 site

  • Cardiology Clinic of Tartu University Clinics

    Tartu, Estonia, 51014

Other trials in Estonia

About this study

Official title: Comparison the Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function and Large Artery Stiffness

An impairment of endothelial function plays the central role in the pathogenesis of cardiovascular diseases and their complications. Most of cardiovascular risk factors are known to impair endothelial function and the established disease further aggravates endothelial dysfunction.

The aim of the present study is to investigate the effects of nebivolol or metoprolol succinate on endothelial function and large artery stiffness.

Read the detailed description

The aim of this study was to compare the effects between the vasodilating β-blocker nebivolol and the cardioselective β-blocker metoprolol succinate on aortic blood pressure and left ventricular wall thickness. We conducted a randomized, double-blind study in 80 hypertensive patients. Patients received either nebivolol 5 mg or metoprolol succinate 50-100 mg daily for one year. Their heart rate, central and brachial blood pressure, mean arterial pressure, augmentation index, carotid-femoral pulse wave velocity and left ventricular wall thickness were measured at baseline and at the end of the study.

Conditions
Hypertension
Being tested
metoprolol succinate, Nebivolol
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • metoprolol succinateDrug

    Also called Corvitol

    once daily 50 or 100 mg for one year

  • NebivololDrug

    Also called Nebilet

    once daily 5 mg capsule for one year

Study groups in NCT01248338
Study groupRoleWhat they receive
metoprolol, tabletsActive comparatormetoprolol succinate 50-100 mg orally daily for one year
Receives: Drug: metoprolol succinate
nebivololExperimentalnebivolol 5 mg capsule once daily for one year
Receives: Drug: Nebivolol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effects of nebivolol and metoprolol on endothelial function

    High-fidelity micromanometer (applanation tonometry) from both wrists and PWA, which is to be performed of the systolic portion (SphygmoCor Px, version 7.0) of the pulse curve.

    Measured: 12 months

Secondary outcomes (3)

  1. Change in carotid artery intima-media thickness

    Ultrasound scanner,with an 12 MHz transducer. Longitudinal images from 3 projections (anterolateral, lateral, and posterolateral) are measured for the common carotid artery, carotid bulb, and internal carotid artery

    Measured: 12 months

  2. Change in left ventricular mass index, systolic and diastolic function

    2-dimensional echocardiography using the standard apical 4-chamber view

    Measured: 12 months

  3. Arterial Compliance

    Peripheral blood pressure and arterial waveform to be measured in the dominant arm by a Cardiovascular Profiling Instrument

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2010 (estimated)
  2. Study startMar 2006
  3. Primary completionDec 2008
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01248338
Sponsor's protocol ID
MeES/05/Neb-EnD/001
Acronym
NEMENDAS
Status last verified
Nov 2010
First submitted
19 Nov 2010
Last updated
25 Nov 2010
Results posted
No
Data monitoring committee
No

Publications

  • Serg M, Kampus P, Kals J, Zagura M, Zilmer M, Zilmer K, Kullisaar T, Eha J. Nebivolol and metoprolol: long-term effects on inflammation and oxidative stress in essential hypertension. Scand J Clin Lab Invest. 2012 Sep;72(5):427-32. doi: 10.3109/00365513.2012.691991. Epub 2012 Jun 18.

    PubMed 22708640

  • Kampus P, Serg M, Kals J, Zagura M, Muda P, Karu K, Zilmer M, Eha J. Differential effects of nebivolol and metoprolol on central aortic pressure and left ventricular wall thickness. Hypertension. 2011 Jun;57(6):1122-8. doi: 10.1161/HYPERTENSIONAHA.110.155507. Epub 2011 May 2.

    PubMed 21536983

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing metoprolol succinate and Nebivolol in people with Hypertension, run by Berlin-Chemie AG Menarini Group at 1 site in Estonia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of nebivolol and metoprolol on endothelial function (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01248338, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2010.

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