Comparison the effects of Nebivolol versus Metoprolol succinate on endothelial function and large artery stiffness.A parallel group, randomized, double-blind, active control phase IV clinical trialNEMENDAS - NEMENDAS

Active, not recruiting

• Conditions: Atherosclerosis

• Registration Number: EUCTR2005-001578-28-EE
• Lead Sponsor: Berlin-Chemie AG Menarini Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 80

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

-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 < 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 ?-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified