Essential Hypertension MedDRA version: 14.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Hypoloc
Product Name: Nebivolol
Product Code: 21458
Pharmaceutical Form: Tablet
INN or Proposed INN: NEBIVOLOL
CAS Number: 99200-09-6
Other descriptive name: Nebivolol
Concentration unit:
Sponsors
Department of Medical Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men and women • Age 40-70 years • Ambulatory blood pressure > 135 mmHg systolic and/or 85 mmHg diastolic in daytime during amlodipine treatment with either 5 or 10 mg • Informed consent • Fertiel women must take contraception 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Diabetes mellitus • eGFR 1,5 g/L • Renografi indicating sekundary hypertension • clinical signs of pheoocromocyta eller abnormal p-metanefrin. • Clinical important signs of lung, heart, liver or thyroid disease l • Clinical important abnormalities in screening blood samples and ECG • Clinical important hypokalimia • Clinical important abnormalities in plasma calcium • Neplastic diseases • Alcoholabuse • Drug or medical abuse • Pregnancy or nursing • Intolerans towards nebivolol • Bloddonationwithin a month • Uacceptable side effects to amlodipine • Ambulatory BP above 170/105 mmHg on hightest dose amlodipine 10mg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose is to investigate if nebivolol is involded in regulation of systemic and renal nitric oxide system;Secondary Objective: The objective is to measure the effect of nebivolol on L-NMMA induced changes in the renal tubular transport of sodium and water (FENa, u-ENaCß, u-ENaC?, CH2O, u-AQP2), hemodynamics (SBP, DBP, hjertefrekvens, central BP, AI) and plasma concentrations of vasoactive homones (renin, aldosterone, atrial natriuretic peptide, brain natriuretic peptide, vasopressin, endothelin) in patients withessential hypertension. ;Primary end point(s): Fractional excretion of sodium (FENa);Timepoint(s) of evaluation of this end point: End of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Systolic BP, Diastolic BP, central BP, Augmentation Index (AI), Arteriel stiffness (Pulse wave velocity). Plasma concentrations of renin, aldosterone, atrial natriuretic peptide, brain natriuretic peptide, vasopressin, endothelin Urinary flow, free water clearance (CH2O), glomerular filtration rate (GFR) Protein excretion from epithelial sodium channels (u- EnaCß, u- EnaC?) and aquaporins (U-AQP2) ;Timepoint(s) of evaluation of this end point: End of trial | — |
Countries
Denmark
Contacts
Public ContactDepartment of Medical Research
Holstebro Hospital
Outcome results
None listed