CureApp has announced the completion of a Phase III clinical trial of its digital therapeutic app (DTx) in Japan to treat hypertension.
The clinical trial began in December 2019. It evaluated the effectiveness and safety of the app when used with hypertension patients without any previous oral treatments using antihypertensive drugs.
Subjects were divided into two groups, a control group that only applied lifestyle changes depending on the Guidelines for the Management of Hypertension 2019 and an intervention group using the CureApp’s DTx app with lifestyle changes proposed in the Guidelines.
Jointly conducted by a team led by Jichi Medical University Professor Kazuomi Kario, the study has shown a significant difference in average systolic blood pressure in 24-hour time, which is the primary endpoint of this study.
This proved that the DTx application had a marked effect in treating hypertension.
Kario said: “The fact that the world’s first hypertension therapeutics app was able to produce a hypotensive effect with relation to the average systolic blood pressure over a 24-hour period, a key evaluation item of this Phase III clinical study (trial), represents a significant step forward for hypertension treatment.
“When treating hypertension, reducing the risk of serious complications through therapeutic intervention and reducing blood pressure at an early stage is vital.”
Hypertension is the highest risk factor that leads to cerebral and cardiovascular diseases such as stroke and heart disease.
According to CureApp, approximately 100,000 people die due to hypertension-induced cerebral and cardiovascular diseases per year and it is estimated that 43 million people in Japan have hypertension.