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) ]

The primary endpoint is the preservation of potassium levels at or above 3.3 mEq/L (milliequivalents per liter). A time to event model using the Log Rank test will be used to compare the Mg Group and those in the Non-Mg Group.


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