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Clinical Trial Details

Trial ID: L1907
Source ID: NCT02709031
Associated Drug: Cicletanine + Magnesium
Title: Cicletanine in Hypertension With Diabetes: Added Magnesium Preserves Potassium and Sodium
Acronym: CHAMP
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Arterial Hypertension|Diabetes|Hypokalemia|Hyponatremia
Interventions: DRUG: Cicletanine + magnesium|DRUG: Cicletanine
Outcome Measures: Primary: Time to potassium rescue, 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., 13 weeks (duration of study) | Secondary: Reduction in systolic blood pressure vs. baseline, Aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible., 13 weeks (duration of study)|Reduction in diastolic blood pressure vs. baseline, Aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible., 13 weeks (duration of study)|Reduction in HbA1c vs. baseline, Aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible., 13 weeks (duration of study)|CRP (C reactive protein) levels, 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., 13 weeks (duration of study)|Average levels of potassium in patients on cicletanine with and without magnesium, The average potassium levels levels in the two groups (cicletanine + magnesium; cicletanine only) will be compared. Subgroup analyses will also be made as feasible., 13 weeks (duration of study)|Average levels of sodium in patients on cicletanine with and without magnesium, The average sodium levels levels in the two groups (cicletanine + magnesium; cicletanine only) will be compared. Subgroup analyses will also be made as feasible., 13 weeks (duration of study)|Average levels of magnesium in patients on cicletanine with and without magnesium, The average magnesium levels levels in the two groups (cicletanine + magnesium; cicletanine only) will be compared. Subgroup analyses will also be made as feasible., 13 weeks (duration of study)
Sponsor/Collaborators: Sponsor: Navitas Pharma | Collaborators: IndiPharm Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-06
Completion Date: 2024-09
Results First Posted:
Last Update Posted: 2021-09-05
Locations:
URL: https://clinicaltrials.gov/show/NCT02709031