PHARMACOKINETICS OF ORAL SPIRONOLACTONE IN CHILDREN UP TO 2 YEARS OF AGE

Phase 1

• Conditions: cardiac failure, ascites and/or oedema; MedDRA version: 17.0Level: HLGTClassification code 10010394Term: Congenital cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 17.0Level: PTClassification code 10049630Term: Oedema due to renal diseaseSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 17.0Level: LLTClassification code 10030103Term: Oedema generalizedSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 17.0Level: PTClassification code 10003445Term: AscitesSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001189-40-EE
• Lead Sponsor: niversity of Tartu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-14
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Inclusion criteria
1.Age 35+0 weeks of gestation up to two years of age
2.Clinical need for spironolactone treatment due to heart failure, ascites, oedema
3.Clinical need for an arterial, central venous or venous catheter
4.Admission to study units
5.Informed consent by the parents or by the legitimate representative of the child.

Are the trial subjects under 18? yes
Number of subjects for this age range: 27
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Acute renal insufficiency, oligoanuria
diuresis <0.5 ml/kg/h; creatinine >100 mcmol/L
2.Addison's disease or other conditions associated with hyperkalemia
3.Hyperkalemia >5.5 mmol/l
4.Hyponatraemia <130.0 mmol/l
5.Hypersensitivity to spironolactone
6.Concomitant use of potassium sparing diuretics

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified