KUALA LUMPUR, March 19 -- CureApp Inc has completed a Japanese Phase III multicentre randomised controlled trial of their digital therapeutics (DTx) app to treat hypertension.
According to a statement, it was jointly researched by a team, led by Professor Kazuomi Kario at Jichi Medical University.
Results of the study showed a statistically significant difference in average systolic blood pressure over a 24-hour period – the primary endpoint of this study, demonstrating a hypotensive effect.
Moving forward, the Company will seek regulatory approval based on the results.
“We view the popularisation of digital therapeutics for hypertension as having the potential to alter hypertension treatments for the better, as well as greatly contribute to reducing medical care expenses,” said CureApp Inc Chief Executive Officer and Practicing Doctor, Kohta Satake.
Having commenced in December 2019, this trial evaluated the efficacy and safety of the DTx app when used with patients with essential hypertension who had not received oral treatments using antihypertensive drugs.
For the comparative study, subjects were divided into two groups. This included a control group that only applied lifestyle changes based on the Guidelines for the Management of Hypertension 2019 and an intervention group using the DTx app in addition to the lifestyle changes proposed in the Guidelines.
Hypertension is the highest risk factor for cerebral and cardiovascular diseases (stroke and heart disease). An estimated 100,000 people die of hypertension induced cerebral and cardiovascular diseases every year.
-- BERNAMA
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