Atherosclerosis
Conditions
Interventions
Product Name: NEBILET®
Pharmaceutical Form: Tablet
Product Name: Beloc-Zok® Herz 23,75 mg
Pharmaceutical Form: Tablet
Product Name: Beloc-Zok® mite 47,5 mg
Pharmaceutical Form: Tablet
Product Name:
Sponsors
Berlin-Chemie AG Menarini Group
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Concomitant medication: Cyclic antidepressants, MAO inhibitors, corticosteroids - Diabetes I or II typus (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) - Arrhytmias and conduction disturbances, requiring therapy, sinus bradycardia at rest 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 ?-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effect of nebivolol as compared to metoprolol on a. endothelial function (e.g. increased Endothelium-dependent/-independent vasodilatation) b. large and small arterial compliance c. large artery stiffness (e.g. change in both augmentation index and in carotid-femoral pulse wave velocity, and change in estimated aortic pulse wave velocity) ;Secondary Objective: a. change in carotid artery intima-media thickness. b. change in left ventricular mass index, systolic and diastolic function. c. change of biomarkers related to endothelial dysfunction (intracellular adhesion molecule, asymmetric dimethylarginine), oxidative stress (oxidized LDL, antibodies against oxidized LDL,, homocysteine, isoprostanoids) and chronic inflammation (high sensitive C-reactive protein, fibrinogen, interleukin-6). ;Primary end point(s): | — |
Countries
Estonia
Outcome results
None listed