Cicletanine in Hypertension With Diabetes: Added Magnesium Preserves Potassium and Sodium

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 30, 2022

Primary Completion Date

June 30, 2024

Study Completion Date

September 30, 2024

Conditions
Arterial HypertensionDiabetesHypokalemiaHyponatremia
Interventions
DRUG

Cicletanine + magnesium

"Cicletanine is an orally-dosed furopyridine drug launched or hypertension in France in 1988 (and soon thereafter in Germany by IPSEN. While the drug's maximum tolerated dose is not known, the principal concern (and so far only material concern) at higher doses is the decrease in levels of sodium and potassium. Trials so far have take n the drug up to 400 mg QD (once daily); it was well tolerated at that dose. The drug has had an excellent safety profile in its \~1.8 million patient-years of post-launch experience,~Magnesium is being added to cicletanine in order to decrease losses of potassium and sodium, thereby enhancing cicletanine's safety at higher doses."

DRUG

Cicletanine

Cicletanine is an orally-dosed furopyridine drug launched or hypertension in France in 1988 (and soon thereafter in Germany by IPSEN. While the drug's maximum tolerated dose is not known, the principal concern (and so far only material concern) at higher doses is the decrease in levels of sodium and potassium. Trials so far have take n the drug up to 400 mg QD; it was well tolerated at that dose. The drug has had an excellent safety profile in its \~1.8 million patient-years of post-launch experience,

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

IndiPharm Inc.

UNKNOWN

lead

Navitas Pharma

INDUSTRY