Hypertension stands as the leading preventable cause of morbidity and mortality worldwide. Despite amlodipine’s status as a first-line recommended anti-hypertensive medication, approximately 20% of patients discontinue its use after just one prescription, often due to undesirable adverse effects like peripheral edema, which correlates strongly with dosage. CLM-HT01 emerges as a promising solution—a novel single-label combination product integrating Closed Loop Medicine’s proprietary software as a medical device (SaMD) with amlodipine, designed to provide more precise, effective, and cost-efficient disease management strategies, ultimately enhancing patient outcomes and streamlining clinician involvement.
The results of our PERSONAL-COVID BP clinical trial, published in the Journal of the American Health Association (JAHA), underscore the potential of our technology in augmenting traditional treatment approaches. This was achieved through personalized adjustment of drug dosages based on data entered by participants into a dedicated smartphone app, securely transmitted to healthcare providers. Clinically significant reductions in blood pressure (BP) were swiftly observed, with a majority of participants achieving BP control and mitigating side effects, even among those previously intolerant to standard amlodipine dosages. The study also reported high rates of adherence, both to the app usage and medication regimen, with remarkably high patient retention and no discontinuations due to drug intolerance. These findings corroborate and extend upon preliminary data published in the Journal of the American College of Cardiology, and the Journal of Human Hypertension.
Results of this clinical trial validate Closed Loop Medicine’s unique approach to precision care to improve patient outcomes at an individual level, and the findings will be used to drive forward our commercial strategy to expand our product portfolio across other therapeutic areas – including within the rapidly-growing GLP-1 market, where we see huge potential to deliver optimized dosing.
Ready to explore the full story? Watch our video abstract and download the full paper for an in-depth look into the PERSONAL COVID PB clinical trial.