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CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)
Sponsor: Certmedica International GmbH
Summary
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.
Official title: Cardio and Atherosclerosis Prevention and Treatment Via Fat Uptake REduction With a Specified Biopolymer: One Year Randomized Double-blind Placebo-controlled Clinical Investigation to Improve Vascular Health in Patients at Cardiovascular Risk: CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)
Key Details
Gender
All
Age Range
45 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2025-04-01
Completion Date
2027-03
Last Updated
2025-04-04
Healthy Volunteers
No
Conditions
Interventions
Polyglucosamine
The 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
2x 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
Locations (3)
Pisa University Hospital - Clinical Research Unit
Pisa, Tuscany, Italy
University Gabriele d'Annunzio Chieti - Pescara
Chieti, Italy
S. Maria della Misericordia Hospital
Perugia, Italy