Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Berlin-Chemie AG Menarini Group
• Treatments: Metoprolol; Nebivolol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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.