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NOT YET RECRUITING
NCT06910111
NA

CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)

Sponsor: Certmedica International GmbH

View on ClinicalTrials.gov

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

Interventions

DEVICE

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

DEVICE

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