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Clinical Trial Summary

Cicletanine, which has been approved and launched for hypertension in France and Germany, has promise beyond hypertension in critically-unmet needs such as diabetes. It is evident from in vitro, animal and human studies that cicletanine's optimal dose in diabetes and other challenging, critically-unmet needs is likely to be higher than that for hypertension. Cicletanine's maximum tolerated dosage is not known, but the drug's dose-limiting effects are documented to be potassium loss and sodium loss from thiazide-type activity (one of the therapeutic mechanisms the drug is known to have); such thiazide-type losses are known to be reversed safely by magnesium. This trial explores the ability of magnesium to enhance cicletanine safety at higher doses in a trial involving patients with hypertension complicated by diabetes.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02709031
Study type Interventional
Source Navitas Pharma
Contact
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date June 2022
Completion date September 2024

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