drugset / Trial / NCT06021860
A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a 2-part, 2 periods per part, open-label study with spironolactone oral suspension in pediatric patients with edema due to HF or hepatic cirrhosis. Both study parts will evaluate the safety, PK and PD of multiple doses of spironolactone in patients aged from birth to ≤17 years of age.
Timeline
- Start
- 2024-06
- Primary completion
- 2025-03
- Completion
- 2025-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spironolactone | Small molecule | 1.5 mg/kg | Oral |
Indications
No indication recorded.