Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function

NCT01248338 | Completed Phase 4

• 1 other identifier: MeES/05/Neb-EnD/001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (3)

• Change in carotid artery intima-media thickness

  12 months

• Change in left ventricular mass index, systolic and diastolic function

  12 months

• Arterial Compliance

  12 months

Study Arms (2)

metoprolol, tablets

ACTIVE COMPARATOR

metoprolol succinate 50-100 mg orally daily for one year

Drug: metoprolol succinate

nebivolol

EXPERIMENTAL

nebivolol 5 mg capsule once daily for one year

Drug: Nebivolol

Interventions

metoprolol succinate DRUG

once daily 50 or 100 mg for one year

Also known as: Corvitol

metoprolol, tablets

Nebivolol DRUG

once daily 5 mg capsule for one year

Also known as: Nebilet

nebivolol

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Berlin-Chemie AG Menarini Group: lead

Study Sites (1)

Cardiology Clinic of Tartu University Clinics

Tartu, Estonia, 51014, Estonia

Location

Related Publications (2)

• 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.

  PMID: 22708640 DERIVED

• 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.

  PMID: 21536983 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Metoprolol; Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Ethanolamines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jaan Eha, Professor

  Cardiology Clinic of Tartu University Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 25, 2010
• Study Start: March 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: November 25, 2010

Record last verified: 2010-11

Locations

ES (1)