The effects of Nebivolol/HCTZ on Central Arterial Pressure, a randomised double-blind cross-over trial - NeMeCAP
- Conditions
- Hypertension
- Registration Number
- EUCTR2009-015824-27-NL
- Lead Sponsor
- MENARINI Benelux NV/SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Secondary Objective: To compare the effects of nebivolol and metoprolol on:<br> -Insulin sensitivity<br> -Lipid profile<br> -The haemodynamic response to nitroglycerin<br> ;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
- Secondary Outcome Measures
Name Time Method