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Clinical trials for Fetal circulation

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    13 result(s) found for: Fetal circulation. Displaying page 1 of 1.
    EudraCT Number: 2011-000203-41 Sponsor Protocol Number: AC-052-391 Start Date*: 2011-09-06
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Multicenter, double-blind, placebo-controlled, randomized, prospective study of bosentan as adjunctive therapy to inhaled nitric oxide in the management of persistent pulmonary hypertension of the ...
    Medical condition: Persistent Pulmonary Hypertension of the Newborn (PPHN)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) NL (Not Authorised) CZ (Prematurely Ended) GB (Completed) FR (Ongoing) BE (Prematurely Ended) PL (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-021266-30 Sponsor Protocol Number: A1481283 Start Date*: 2011-12-14
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A FOLLOW UP INVESTIGATION FOR PATIENTS COMPLETING STUDY A1481276 TO INVESTIGATE DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS FOLLOWING COMPLETION OF SILDENAFIL TREATMENT
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-016248-37 Sponsor Protocol Number: A1481276 Start Date*: 2010-07-15
    Sponsor Name:Pfizer Ltd., Ramsgate Road, Sandwich, Kent. CT13 9NJ UNITED KINGDOM
    Full Title: A SINGLE ARM SINGLE CENTRE STUDY TO INVESTIGATE SAFETY AND EFFICACY OF SILDENAFIL IN NEAR TERM AND TERM NEWBORNS WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN)
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-001829-27 Sponsor Protocol Number: AC-052-392 Start Date*: Information not available in EudraCT
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Multi-center non-drug-interventional extension study to assess long-term safety and effects on growth in patients who received bosentan or placebo as adjunctive therapy to inhaled nitric oxide for ...
    Medical condition: Persistent Pulmonary Hypertension of the Newborn (PPHN)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) PL (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2011-001893-24 Sponsor Protocol Number: Bay63-2521/14986 Start Date*: 2011-10-13
    Sponsor Name:Bayer HealthCare AG
    Full Title: Relative bioavailability and food effect study of two oral liquid formulations in comparison to a 1mg tablet of riociguat to characterize its pharmacokinetic properties in healthy male and female a...
    Medical condition: Children with PH due to • Pulmonary arterial hypertension (PAH) • persistent pulmonary hypertension of the newborn (PPHN)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037405 Pulmonary hypertension primary LLT
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10036727 Primary pulmonary hypertension LLT
    14.0 10010331 - Congenital, familial and genetic disorders 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002619-24 Sponsor Protocol Number: A1481316 Start Date*: 2013-03-04
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONA...
    Medical condition: Persistent pulmonary hypertension of the newborn
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) SE (Completed) ES (Prematurely Ended) AT (Completed) DE (Completed) NO (Completed) IT (Completed) NL (Completed) DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-002988-16 Sponsor Protocol Number: MINT-2014-01 Start Date*: 2015-07-01
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: The Use of Milrinone in Neonates with Persistent Pulmonary Hypertension of the Newborn: A Randomised Controlled Trial Pilot Study (MINT 1)
    Medical condition: Persistent Pulmonary Hypertension of the Newborn
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-005398-32 Sponsor Protocol Number: STRIDER Start Date*: 2014-07-18
    Sponsor Name:Liverpool Women's NHSFT [...]
    1. Liverpool Women's NHSFT
    2. University of Liverpool
    Full Title: A randomised controlled trial of sildenafil therapy in dismal prognosis early-onset intrauterine growth restriction
    Medical condition: Early onset intrauterine growth restriction
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004868 10022819 Intrauterine growth retardation LLT
    Population Age: Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-000185-59 Sponsor Protocol Number: 12012015 Start Date*: 2015-03-03
    Sponsor Name:Merja Kokki
    Full Title: The effect of oxycodone to placental and fetal circulation during the phase I of labor and the efficacy, safety and neonatal effects of oxycodone.
    Medical condition: Labor pain at the onset of labor in previously healthy women with normal pregnancy
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004868 10059210 Labor pain LLT
    Population Age: In utero, Newborns, Under 18, Adults Gender: Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003459-12 Sponsor Protocol Number: RB-NAIT-01-01 Start Date*: 2020-08-11
    Sponsor Name:Rallybio, IPA, LLC
    Full Title: A Single-blind, Placebo-controlled, Single-center Study Investigating the Dose of Human Anti-Human Platelet Antigen (HPA)-1a Immune Globulin (NAITgam) Needed to Eliminate HPA-1a Positive Platelets ...
    Medical condition: prevention of Fetal Neonatal Alloimmune Thrombocytopenia (FNAIT In mothers negative for HPA-1a antigen, fetal platelets positive for HPA-1a antigen, may enter the mother’s circulation and induce pr...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10075151 Fetal and neonatal alloimmune thrombocytopenia LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003138-18 Sponsor Protocol Number: UCC-Strider Start Date*: Information not available in EudraCT
    Sponsor Name:University College Cork
    Full Title: STRIDER Ireland: A Randomised Controlled Trial of Sildenafil Therapy In Dismal Prognosis Early‐Onset Intrauterine Growth Restriction
    Medical condition: Severe early - onset Intrauterine Growth Restriction (IUGR), (also referred to as Fetal growth restriction) diagnosed between 22+0 and 29+6 gestational age. IUGR is defined as an estimated fetal we...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10070532 Fetal growth restriction LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003181-12 Sponsor Protocol Number: HOTPOT1 Start Date*: 2016-10-07
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension?
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occur...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000727-17 Sponsor Protocol Number: 281274 Start Date*: 2007-08-23
    Sponsor Name:Erasmus MC
    Full Title: Maternal, uteroplacental and fetal haemodynamic effect of Nicardipine in severe pre-eclampsia.
    Medical condition: Hypertensive crisis in patients with severe pre-eclampsia needs to be treated to prevent maternal and fetal complications. The maternal, uteroplacental and fetal haemodynamic respose to antihypert...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10040445 Severe pre-eclampsia, antepartum LLT
    9.1 10053094 Doppler echocardiography LLT
    9.1 10045412 Ultrasound Doppler LLT
    9.1 10058179 Hypertensive emergency LLT
    9.1 10038555 Renin LLT
    9.1 10002491 Angiotensin II LLT
    9.1 10053406 Brain natriuretic peptide LLT
    9.1 10001644 Aldosterone LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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