Hyperkalaemia
Conditions
Brief summary
CP primary endpoint: Normokalaemia achieved in the CP within 3 days (yes/no), 28-day MP primary endpoint:Serum potassium (S-K+) value within normokalaemia range (yes/no) at each of the last two scheduled visits in the MP
Detailed description
All phases secondary endpoint: S-K+ level at each scheduled visit, MP secondary endpoints: Change in serum aldosterone levels from baseline to Week 3 of the MP Change in serum electrolytes (including bicarbonate), and spot urinary pH and urinary electrolytes from baseline to week 3 of the MP, LTMP secondary endpoints: S-K+ value within normokalaemia range (yes/no) at each scheduled visit in the LTMP
Interventions
DRUGAZD7270
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CP primary endpoint: Normokalaemia achieved in the CP within 3 days (yes/no), 28-day MP primary endpoint:Serum potassium (S-K+) value within normokalaemia range (yes/no) at each of the last two scheduled visits in the MP | — |
Secondary
| Measure | Time frame |
|---|---|
| All phases secondary endpoint: S-K+ level at each scheduled visit, MP secondary endpoints: Change in serum aldosterone levels from baseline to Week 3 of the MP Change in serum electrolytes (including bicarbonate), and spot urinary pH and urinary electrolytes from baseline to week 3 of the MP, LTMP secondary endpoints: S-K+ value within normokalaemia range (yes/no) at each scheduled visit in the LTMP | — |
Countries
Germany, Poland, Romania, Spain
Outcome results
None listed