WHO ICTRP trial

Paracetamol versus ibuprofen in preterm infants with a hemodynamically…

EUCTR2015-003177-14-ES · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2015-003177-14-ES
Public title Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.
Scientific title Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Spain
Conditions Persistent ductus arteriosus haemodynamically significant;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Interventions Product Name: Paracetamol Pharmaceutical Form: Solution for injection INN or Proposed INN: Paracetamol CAS Number: 103-90-2 Other descriptive name: PARACETAMOL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal…
Registration date Apr 20, 2016
Secondary IDs IBUPAR-Trial
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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