Clinical Trial: Cicletanine in Hypertension With Diabetes: Added Magnesium Preserves Potassium and Sodium
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Cicletanine in Hypertension With Diabetes: Added Magnesium Preserves Potassium and Sodium
Brief 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.
Detailed Summary:
Sponsor: Navitas Pharma
Current Primary Outcome: Time to potassium rescue [ Time Frame: 13 weeks (duration of study) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Reduction in systolic blood pressure vs. baseline [ Time Frame: 13 weeks (duration of study) ]Aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible.
- Reduction in diastolic blood pressure vs. baseline [ Time Frame: 13 weeks (duration of study) ]Aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible.
- Reduction in HbA1c vs. baseline [ Time Frame: 13 weeks (duration of study) ]Aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible.
- CRP (C reactive protein) levels [ Time Frame: 13 weeks (duration of study) ]
CRP (C-reactive protein) is a measure of general inflammation.
This will be an aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible.
- Average levels of potassium in patients on cicletanine with and without magnesium [ Time Frame: 13 weeks (duration of study) ]The average potassium levels levels in the two groups (cicletanine + magnesium; cicletanine only) will be compared. Subgroup analyses will also be made as feasible.
- Average levels of sodium in patients on cicletanine with and without magnesium [ Time Frame: 13 weeks (duration of study) ]The average sodium levels levels in the two groups (cicletanine + magnesium; cicletanine only) will be compared. Subgroup analyses will also be made as feasible.
- Average levels of magnesium in patients on cicletanine with and without magnesium [ Time Frame: 13 weeks (duration of study) ]The average magnesium levels levels in the two groups (cicletanine + magnesium; cicletanine only) will be compared. Subgroup analyses will also be made as feasible.
Original Secondary Outcome: Same as current
Information By: Navitas Pharma
Dates:
Date Received: March 10, 2016
Date Started: June 2016
Date Completion: September 2017
Last Updated: March 10, 2016
Last Verified: March 2016