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NOT YET RECRUITING
NCT06021860
PHASE4

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

Sponsor: CMP Development, LLC

View on ClinicalTrials.gov

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.

Official title: A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Single and Multiple Doses of Spironolactone Oral Suspension in Pediatric Patients With Edema Due to Heart Failure or Cirrhosis

Key Details

Gender

All

Age Range

Any - 17 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2027-06

Completion Date

2028-12

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

DRUG

Spironolactone Oral Suspension

Spironolactone will be dosed on a mg/kg basis, with actual weight on Day 1 (pre-dose) determining the spironolactone suspension volume administered. Therefore, for a given patient, the dose administered on Day 1, based on the weight measured on Day 1, will be administered throughout their participation in the study. Spironolactone will be administered as a single dose in the single-dose periods (Group 4, Parts 1 and 2), and as QD dosing in the multiple-dose periods (Groups 1 to 4, Parts 1 and 2). The low and high doses to be administered during Part 2 of the study will be determined by the Safety Review Committee following their review of Part 1 data.