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Clinical trials for Treprostinil sodium

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   44337   clinical trials with a EudraCT protocol, of which   7367   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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    8 result(s) found for: Treprostinil sodium. Displaying page 1 of 1.
    EudraCT Number: 2021-004002-21 Sponsor Protocol Number: Bio-Eq-20 Start Date*: 2021-11-26
    Sponsor Name:AOP Orphan Pharmaceuticals GmbH
    Full Title: A single center, open-label, two-period, non-randomized, paired-design study to compare steady-state plasma levels following switch from a 10 mg/ml treprostinil formulation to a 20 mg/ml treprostin...
    Medical condition: pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002444-24 Sponsor Protocol Number: HS-18-638 Start Date*: 2020-02-18
    Sponsor Name:Camurus AB
    Full Title: An Exploratory Trial Assessing Vascular Digital Perfusion, Pharmacokinetics, Safety and Tolerability Following a Single Dose of CAM2043 (Treprostinil Subcutaneous Depot) in Patients with Raynaud’s ...
    Medical condition: Raynaud’s phenomenon secondary to systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10047065 - Vascular disorders 10037912 Raynaud's phenomenon PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2008-006441-10 Sponsor Protocol Number: 116-02 Start Date*: 2009-06-03
    Sponsor Name:SCIPHARM SáRL
    Full Title: A double blind controlled clinical study to investigate the efficacy and tolerability of subcutaneous Treprostinil sodium in patients with severe non-operable Chronic Thromboembolic Pulmonary Hyper...
    Medical condition: Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) SK (Completed) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003414-40 Sponsor Protocol Number: LTI-201 Start Date*: 2019-01-31
    Sponsor Name:Liquidia Technologies, Inc.
    Full Title: A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1...
    Medical condition: Pulmonary Arterial Hypertension (WHO Group 1)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077739 Pulmonary arterial hypertension WHO functional class I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-003236-59 Sponsor Protocol Number: LRX –TRIUMPH-001 Start Date*: 2005-06-30
    Sponsor Name:United Therapeutics Corporation
    Full Title: Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.
    Medical condition: NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) AT (Completed) BE (Completed) DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-004631-31 Sponsor Protocol Number: REM-PH-416 Start Date*: 2012-03-13
    Sponsor Name:United Therapeutics Corp.
    Full Title: A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pul...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10065151 Idiopathic pulmonary arterial hypertension LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10065152 Familial pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-003401-21 Sponsor Protocol Number: 11PHR02 Start Date*: 2011-11-09
    Sponsor Name:CHU GRENOBLE
    Full Title: Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study
    Medical condition: Sclérodermie systémique avec sclérodactylie : forme cutanée limitée selon les critères de LeRoy et Medsger (LeRoy and Medsger 2001)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-001312-59 Sponsor Protocol Number: CRO1824 Start Date*: 2011-06-24
    Sponsor Name:Imperial College London
    Full Title: A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remoduli...
    Medical condition: Pulmonary arterial hypertension (PAH) is a rare life-threatening disease characterised by high blood pressure in the arteries to the lungs, rapidly evolving in a clinical syndrome of dyspnoea and f...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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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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