Assessment of Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension

Launched by NEWEL HEALTH SRL · Oct 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Amicomed® to see how well it works and how safe it is for people with essential hypertension, which is a condition where blood pressure is higher than normal. The trial will compare Amicomed® to standard care over a 24-week period. To participate, individuals need to be at least 18 years old, have been diagnosed with essential hypertension, and have a specific level of high blood pressure. They should also have been living with this condition for about a year and either not be on any medication or be on a stable treatment that hasn't been effective.

Participants in the trial can expect to attend regular clinic visits and will need to use an app to track their blood pressure readings at home. This helps ensure they are following the study requirements. It’s important to note that people who are pregnant, have severe kidney or liver problems, or are currently undergoing cancer treatment cannot participate. This study aims to find out if Amicomed® can provide better management of high blood pressure for those who need it.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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