This clinical investigation is intended to confirm the application of a new intended purpose and a new indication for an already certified medical device. Therefore, it is a pivotal clinical investigation with a confirmatory type of design.
Outpatients of both genders, with CIMT > 1.00 mm suffering from hypertension and/or type II diabetes and/or hypercholesterolemia, under stable treatment for these conditions since at least 6 months.
Age between 45-65
BMI > 26 ≤35
Total cholesterol ≥ 200 ≤ 240 mg/dL
Age < 45 or > 65 years.
Pregnancy or breastfeeding. During the study, women of reproductive age will have to use reliable contraceptive methods.
Mx BP > 160 Mn > 90 despite a treatment of 6 months with common antihypertensive
Total cholesterol > 240 mg/dL despite a treatment of 6 months with the common hypolipemic drugs
Certmedica International GmbH
Lead sponsor
Evidilya S.r.l.
Collaborator