Effects of eplerenone on forearm blood flow

• Conditions: healthy volunteers; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2013-000189-12-NL
• Lead Sponsor: niversity Medical Centre Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-08
• Last Update Posted: 25 March 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

male sex, age 18-40 years, healthy, written informed consent
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 14
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

potassium >4.8 mmol/L, smoking, hypertension (SBP >140 or DBP >90 mmHg), hypotension (SBP <100 or DBP <60 mmHg), diabetes mellitus (fasting glucose >7.0 mmol/L or random >11.0 mmol/L), history of any cardiovascular disease, angina pectoris, history of COPD or asthma, alcohol and/or drug abuse, concomitant use of medication, renal dysfunction (MDRD <60 mL/min), liver enzyme abnormalities (ALAT >twice upper limit), fasting total cholesterol >6 mmol/L, 2nd/3rd degree AV block on electrocardiography. During the study a serum potassium of >5.2 mmol/L is an exclusion criterium.

Study & Design

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