Japanese digital health therapeutic firm CureApp has started a Phase 3 clinical trial of its ‘Digital Therapeutics’ for hypertension, in collaboration with Jichi Medical University in Japan.
CureApp said that the new clinical study is designed to evaluate the efficacy and safety of ‘Digital Therapeutics’ in hypertension patients, who have not received an orally administered antihypertensive drug treatment.
In addition, the clinical trial will include various partners, including professor Kazuomi Kario from the division of cardiovascular medicine at Jichi Medical University School of Medicine.
CureApp president and CEO Kohta Satake said: The spread of ‘Hypertension Digital Therapeutics’ as a treatment covered by health insurance will lead to preventing the progression of hypertension and inhibiting cardiovascular diseases. After this clinical trial, we aim to obtain regulatory approval and health insurance coverage.
‘Digital Therapeutics’ can provide appropriate medical guidance to patients at home and outside the hospital, making it possible to provide high-quality personalized medical care to people of working age who find it difficult to make frequent visits to clinics, as well as people in remote areas.”
Digital Therapeutics is a new treatment method that makes use of mobile technology
According to the company, hypertension is one of the biggest risk factor for cerebrovascular and cardiovascular diseases, where lifestyle improvements plays crucial role in treatment of the disease, and are difficult to sustain as they depend on motivation and environment of the patient.
Digital Therapeutics is a new treatment method that leverages mobile technology to deliver superior therapeutic effect, enabling patients to return to normal blood pressure and develop appropriate lifestyle habits.
The new treatment method is said to provide personalised, optimised treatment guidance to individual patients based on medical evidence and encouraging awareness/behavior changes, said the company.
The patients in the study will be divided into two groups, where the first one will use ‘Digital Therapeutics’ in addition to lifestyle changes, and the second group will only adopt the lifestyle habit changes without using ‘Digital Therapeutics’.
The lifestyle changes will be set according to the guidelines for the management of Hypertension 2019, and the treatment application will automatically analyse blood pressure and lifestyle characteristics of individuals.
