Hypertension
Conditions
Interventions
Trade Name: Nobiten tablets
Product Name: Nebivolol
Product Code: C07AB12
Pharmaceutical Form: Tablet
INN or Proposed INN: HYDROCHLOROTH
Sponsors
MENARINI Benelux NV/SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male or female - age 40-70 years - Caucasian - Receiving treatment for or diagnosed with grade 2 hypertension at the outpatient clinic (BP 160-179 mmHg systolic and/or 100-109 mmHg diastolic without treatment or BP 140-159 systolic and/or 90-99 mmHg diastolic while taking one or two oral antihypertensive drugs - Whilling and medically able to discontinue anti-hypertensive therapy for the duration of the wash-out periods - Willing and medically able to take the study medication 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or nursing women, women or child-bearing potential without adequate contraception (adequate are: oral contraceptives, intra-uterine device or barrier method) - Contraindications for beta-blockers (COPD, bradycardia with pulse <60 bts/min, bradyarrythmias or sick-sinus syndrome, 2nd and 3rd degree AV-block - Chronic atrial fibrillation - Previous intolerance for or side-effects related to beta-blocker and/ot thiazide therapy - Taking medication that can influence blood pressure during the study period (e.g. corticosteroid therapy, regular use of NSAID’s) - Secondary hypertension - Diabetes mellitus (fasting glucose = 7.0 mmol/l or glucose lowering therapy) - Dyslipidemia ( fasting cholesterol = 6.5 mmol/l) - Renal dysfunction (serum creatinine = 150 µmol/l) - Evidence for current or previous cardiovascular disease (including, but not limited to ischemic heart disease, chronic heart failure) - Previous admission for malignant hypertension or other hypertensive crises - Any contra-indication according to the SPC of either metoprolol/HCTZ or Nebivolol/HCTZ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare the effects of nebivolol and metoprolol on: - Insulin sensitivity - Lipid profile - The haemodynamic response to nitroglycerin ;Primary end point(s): Differences in central and peripheral blood pressure of metorprolol/HCTZ versus nebivolol/HCTZ as assessed non-invasively by applanation-tonometry;Main Objective: To compare differences in central and peripheral blood pressure between nebivolol/HCTZ and metoprolol/HCTZ as assessed non-invasively by applanation tonometry | — |
Countries
Netherlands
Outcome results
None listed