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
Parallel
Polyglucosamine
DeviceThe treatment will continue for 12 months administering a customized Polyglucosamine (formoline AtheroGuard) (twice/day) before the two main meals for a total of 4 tabs/day (each tab consists of 750 mg). Controls will be conducted at screening/baseline, and after 3/6/9 and 12 months
Placebo
Device2x 2 Placebo tablets The treatment will continue for 12 months administering Placebo (twice/day) before the two main meals for a total of 4 tabs/day. Controls will be conducted at screening/baseline, and after 3/6/9 and 12 months
The primary endpoint of the study is the reduction or stabilization of CIMT progression (measured through ultrasound)
To demonstrate the benefit of formoline AtheroGuard reducing or stabilizing CIMT and plaques volume in patients suffering from dyslipidemia, hypertension, or type II diabetes.
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Certmedica International GmbH
Lead sponsor
Evidilya S.r.l.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
