Effects Of The Administration Of Nebivolol Versus Carvedilol On Microcirculatory Endothelial Function, Arterial Stiffness And Wave Reflection In Healthy Volunteers” (NeCaMic-study) - NeCaMic

Phase 1

• Conditions: Microcirculatory Endothelial Function, Arterial Stiffness And Wave Reflection

• Registration Number: EUCTR2009-014643-36-BE
• Lead Sponsor: MENARINI Benelux NV/SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-15
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

• Male volunteers
• = 18 year old at the randomisation visit and = 75 year old
• Normotensive volunteers : SBP <140mm Hg and DBP < 90
• Caucasians volunteers
• Given informed consent
• Normal sinus rhythm with FC >60 BPM

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

• Cardiovascular disease (such as unstable angina, sick sinus syndrome,
heart failure with LVEF < 50%, valvular disease, unstable ischemic heart
disease, antecedent of ventricular arrhythmia, syncope, branch block on
the ECG, …) if clinically significant, at the discretion of the Investigator
• Myocardial infarction or cerebrovascular event within the previous 3
months
• Use of any medication during the trial
• Use of non ocular ß-blockers within the previous month
• Chronic obstructive pulmonary disease (COPD) or bronchial asthma
• Severe peripheral vascular disease
• Diabetes mellitus type 1 or type 2
• serum creatinine >2.5 mg/dl
• Creatinine clearance< 50 ml/ min
• Disabling or terminal illness
• History of sensitivity or significant adverse reactions to ß-blocker therapy
• Severe obesity (Body Mass Index>35 kg/m²)
• Cannabis or other drug abuse
• Use of anti-inflammatory drugs within the past 2 weeks even topically
apply
• Excessive use of Alcohol (at the discretion of the Investigator)

Study & Design

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