Effekts of nebivolol on the nitric oxide system in patients with high blood pressure

Phase 1

Conditions: Essential Hypertension
MedDRA version: 14.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Registration Number: EUCTR2012-001131-31-DK

Lead Sponsor: Department of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 25

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

•Diabetes mellitus
•eGFR < 30
•Albuminuria > 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Systolic BP, Diastolic BP, central BP, Augmentation Index (AI), Arteriel stiffness (Pulse wave velocity).<br>Plasma concentrations of renin, aldosterone, atrial natriuretic peptide, brain natriuretic peptide, vasopressin, endothelin<br>Urinary flow, free water clearance (CH2O), glomerular filtration rate (GFR)<br>Protein excretion from epithelial sodium channels (u- EnaCß, u- EnaC?) and aquaporins (U-AQP2)<br>;Timepoint(s) of evaluation of this end point: End of trial