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Clinical trials for Treprostinil

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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    26 result(s) found for: Treprostinil. Displaying page 1 of 2.
    1  2  Next»
    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: 2021-003294-66 Sponsor Protocol Number: INS1009-211 Start Date*: 2022-06-01
    Sponsor Name:Insmed Incorporated
    Full Title: A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hyperten...
    Medical condition: Pulmonary Hypertension Associated with Interstitial Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077731 Pulmonary hypertension WHO functional class I LLT
    20.0 100000004855 10077732 Pulmonary hypertension WHO functional class II LLT
    20.0 100000004855 10077733 Pulmonary hypertension WHO functional class III LLT
    20.0 100000004855 10077734 Pulmonary hypertension WHO functional class IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001951-18 Sponsor Protocol Number: INS1009203 Start Date*: 2023-03-17
    Sponsor Name:Insmed Incorporated
    Full Title: An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
    Medical condition: Participants with 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, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) DK (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-006978-15 Sponsor Protocol Number: TDE-DU-202 Start Date*: 2009-03-05
    Sponsor Name:United Therapeutics Corporation
    Full Title: DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study
    Medical condition: Systemic Sclerosis, scleroderma digital ulcers
    Disease: Version SOC Term Classification Code Term Level
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10039710 Scleroderma PT
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10042953 Systemic sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-009366-13 Sponsor Protocol Number: TDE-PH-308 Start Date*: 2009-09-02
    Sponsor Name:United Therapeutics Corporation
    Full Title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hyp...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) BE (Completed) AT (Completed) DE (Completed) ES (Completed) SE (Completed) PT (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001950-45 Sponsor Protocol Number: INS1009-212 Start Date*: 2023-02-14
    Sponsor Name:INSMED INCORPORATED
    Full Title: An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Assoc...
    Medical condition: Pulmonary Hypertension Associated with Interstitial Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077731 Pulmonary hypertension WHO functional class I LLT
    20.0 100000004855 10077732 Pulmonary hypertension WHO functional class II LLT
    20.0 100000004855 10077733 Pulmonary hypertension WHO functional class III LLT
    20.0 100000004855 10077734 Pulmonary hypertension WHO functional class IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) DE (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    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: 2021-001528-16 Sponsor Protocol Number: INS1009-202 Start Date*: 2022-05-30
    Sponsor Name:Insmed Incorporated
    Full Title: A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to valuate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in participants with Pu...
    Medical condition: Participants with 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, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Trial now transitioned) AT (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000098-21 Sponsor Protocol Number: TDE-PH-311 Start Date*: 2012-11-06
    Sponsor Name:United Therapeutics Corporation
    Full Title: An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) NL (Completed) AT (Completed) FR (Completed) IT (Completed) SE (Completed) BE (Completed) DK (Completed) GR (Completed) PL (Completed)
    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: 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: 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: 2008-005018-39 Sponsor Protocol Number: TDE-DU-201 Start Date*: 2009-03-05
    Sponsor Name:United Therapeutics Corporation
    Full Title: DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study
    Medical condition: Systemic Sclerosis, scleroderma digital ulcers
    Disease: Version SOC Term Classification Code Term Level
    9.1 10042953 Systemic sclerosis LLT
    9.1 10039710 Scleroderma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 2006-000804-18 Sponsor Protocol Number: TDE-PH-304 Start Date*: 2007-02-15
    Sponsor Name:United Therapeutics Corporation
    Full Title: An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension
    Medical condition: Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with : 1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 ...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10037400 Pulmonary hypertension PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) NL (Completed) AT (Completed) FR (Completed) BE (Completed) IT (Completed) DE (Completed) SE (Completed) PT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2023-001028-40 Sponsor Protocol Number: RIV-PN-201 Start Date*: 2024-01-15
    Sponsor Name:United Therapeutics Corp
    Full Title: Intravenous Remodulin (Treprostinil) as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Randomized, Placebo-Controlled, Safety and Efficacy Study
    Medical condition: Persistant Pulmonary Hypertension of the Newborn (PPHN)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-000097-26 Sponsor Protocol Number: TDE-PH-310 Start Date*: 2012-11-06
    Sponsor Name:United Therapeutics Corporation
    Full Title: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) AT (Completed) NL (Completed) IT (Completed) SE (Completed) BE (Completed) DK (Completed) GR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2006-000801-50 Sponsor Protocol Number: TDE-PH-302 Start Date*: 2007-02-19
    Sponsor Name:United Therapeutics Corporation
    Full Title: A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arteria...
    Medical condition: Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with: 1) Appetite suppressant/toxin use, or 2) Repaired congenital systemic-to-pulmonary shunts (repaired ≥...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) FR (Completed) BE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-005881-17 Sponsor Protocol Number: RIN-PF-303 Start Date*: 2022-08-18
    Sponsor Name:UNITED THERAPEUTICS CORPORATION
    Full Title: A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (TETON-2)
    Medical condition: Idiopathic Pulmonary Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DK (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) NL (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-000800-17 Sponsor Protocol Number: TDE-PH-301 Start Date*: 2007-02-15
    Sponsor Name:United Therapeutics Corporation
    Full Title: A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin...
    Medical condition: Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with: 1) Appetite suppressant use, or 2) Repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 yea...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10037400 Pulmonary hypertension PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) NL (Completed) AT (Completed) FR (Completed) BE (Completed) IT (Completed) DE (Completed) ES (Completed)
    Trial results: View results
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