Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week intake of PADMA 28 on the endothelial function, biomarkers and the autonomic nervous systems in patients with coronary artery disease. The investigators hypothesize that PADMA 28 has a beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen and the blood inflammatory markers in patients with coronary artery disease compared to placebo treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne

Criteria

Inclusion Criteria:

• Male patient with coronary artery disease

• Stable medication

• Physically stable

• Psychologically stable

• Written informed consent

• Willing and able to comply with all trial requirements

• Must have completed rehabilitation program since at least 6 months and no longer than 5 years prior to study begin

Exclusion Criteria:

• Acute coronary syndrome within the last three months

• Abnormal high hepatic enzymes

• Renal insufficiency with compensated retention

• Intake of medication which may affect endothelial function

• Currently smoking

• Current malignant diseases, which may reduce the expectancy of life

• Chronic heart failure

• Insulin-dependent diabetes

• Known hypersensitivity against any ingredient of PADMA 28

• Longterm intake of supplements

• Serious mental health issues

• Alcohol and/or drug abuse

• Simultaneous participation in another clinical trial