Status:
UNKNOWN
Assessment of Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension
Lead Sponsor:
Newel Health SRL
Conditions:
Essential Hypertension
Primary Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a multicenter, randomized, single-blind, parallel-group study to evaluate the efficacy and safety of Amicomed® compared with Usual Care (UC) over a 24-week treatment period in subjects with es...
Detailed Description
Amicomed is a Digital therapeutics service and program for BP management and reduction. The key features of Amicomed include: 1. an automatic, expert system based, finite-machine AI algorithm for ass...
Eligibility Criteria
Inclusion
- Male or female with age ≥ 18 years
- Diagnosed with essential hypertension and exhibiting a mean home-based SBP ≥ 140 and/or DBP \> 90mm Hg, i.e., Grade I Hypertension .
- Disease duration: 12 (+/-) 3 months
- Unmedicated, or currently treated by a stable regimen for hypertension with sub-optimal response to usual care treatments (Delta SBP \< 5 mm Hg; and/or Delta DBP \< 5 mm Hg)
- Not participating in physical exercise or dietary programs during the last 12 months from Visit 1.
- Willing and able to return for all clinic visits and to complete all study-required procedures
- Able to use the app, \[self-report compliance over 80%\]. Compliance is defined as the capacity to provide at least 6 BP measurements per week during the beginning, middle and end week of the 24 weeks program.
Exclusion
- Pregnancy or planning to become pregnant during the study period
- Use of medications that may interfere with the study intervention
- Severe kidney or liver disease
- Active cancer treatment
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT06091176
Start Date
November 1 2024
End Date
October 31 2025
Last Update
October 23 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.