null - FindTrial

N/A - TRIOCAPI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003063-30-FR

Enrollment

385

Registered

2011-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 14.1 Level: PT Classification code 10034130 Term: Patent ductus arteriosus System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: PEDEA Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: 385 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

France

Contacts

Public ContactDirection de la Recherche

CHU NANTES

damien.fairier@chu-nantes.fr00332 53 48 28 84

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 24, 2026