Overview

A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients

Status:
Not yet recruiting

Trial end date:
2025-03-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 4

Details

Lead Sponsor:

CMP Development, LLC

Treatments:

Spironolactone