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Clinical trials for Principle of double effect

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    20 result(s) found for: Principle of double effect. Displaying page 1 of 1.
    EudraCT Number: 2017-000789-31 Sponsor Protocol Number: RGH201 Start Date*: 2018-02-09
    Sponsor Name:Kuopio University Hospital Heart Center
    Full Title: Clinical development and proof of principle testing of new regenerative VEGF-D therapy for cost-effective treatment of refractory angina. A phase II randomized, double-blinded, placebo-controlled s...
    Medical condition: Refractory angina
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10064262 Refractory angina pectoris LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003725-42 Sponsor Protocol Number: R121178 Start Date*: 2018-03-23
    Sponsor Name:University of Manchester
    Full Title: Does Interleukin-1 Receptor Antagonist Improve Outcome following aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III trial
    Medical condition: subarachnoid haemorrhage
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022117 - Injury, poisoning and procedural complications 10042316 Subarachnoid haemorrhage PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2012-002947-74 Sponsor Protocol Number: 1-12 Start Date*: 2013-07-19
    Sponsor Name:Medizinische Universität Wien
    Full Title: A prospective randomized, double blind, placebo-controlled, cross-over study to investigate the analgesic effect of Aspirin® to prevent the pain during the treatment with capsaicin patch 8% (Qutenza®)
    Medical condition: Qutenza is an approved product for the treatment of pain due to postherpetic neuralgia and peripheral neuropathies. Since its application is painful, it is often necessary to give analgesics or loc...
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2007-002114-19 Sponsor Protocol Number: 9831-CL-0301 Start Date*: 2008-02-27
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A phase II, randomized, double-blind, parallel-group, placebo-controlled, 12-week treatment, adaptive proof-of-principle study of twice daily oral dosing of a novel PDE4 inhibitor (ASP9831) in subj...
    Medical condition: Non-alcoholic Steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10053219 Non-alcoholic steatohepatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) CZ (Completed) FR (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004879-19 Sponsor Protocol Number: 0476-377 Start Date*: 2008-02-08
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Evaluate the Effects of a Single Oral Dose of Montelukast, Compared With Placebo, on Exercise-Induced Bronchoconstriction (EIB) i...
    Medical condition: Exercise Induced Bronchoconstriction (EIB)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006464 Bronchoconstriction LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002912-25 Sponsor Protocol Number: 1VIT15043 Start Date*: 2019-11-18
    Sponsor Name:American Regent, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency
    Medical condition: Heart Failure with Iron Deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10022974 Iron deficiency anemia LLT
    20.0 100000004849 10019279 Heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) HU (Completed) CZ (Completed) LT (Completed) LV (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000748-16 Sponsor Protocol Number: MT-2-01 Start Date*: 2017-09-14
    Sponsor Name:Minoryx Therapeutics S.L.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN M...
    Medical condition: ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) HU (Completed) ES (Ongoing) NL (Completed) PL (Prematurely Ended) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001215-39 Sponsor Protocol Number: NN9828-4150 Start Date*: 2015-08-28
    Sponsor Name:Novo Nordisk A/S
    Full Title: A randomised, double-blind, double-dummy, placebo-controlled, parallel-group multi-centre clinical proof-of-principle trial in adult subjects with newly diagnosed type 1 diabetes mellitus investiga...
    Medical condition: Diabetes Mellitus, Type 1
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10045228 Type I diabetes mellitus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) PT (Completed) DK (Completed) FI (Completed) ES (Completed) IE (Completed) PL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-005627-32 Sponsor Protocol Number: IIVOP Start Date*: 2014-06-12
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
    Full Title: A randomised, double blind, placebo controlled crossover study of the influence of the HCN channel blocker ivabradine in a healthy volunteer pain model - an enriched population study
    Medical condition: Neuropathic Pain
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004852 10054095 Neuropathic pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-000323-86 Sponsor Protocol Number: N/A Start Date*: 2017-05-05
    Sponsor Name:University of Oxford
    Full Title: A randomised, parallel group, double blind, placebo controlled, add on clinical trial to investigate whether the lithium mimetic, ebselen, can reduce symptoms of hypomania and mania in bipolar pati...
    Medical condition: Patients with bipolar disorder meeting DSM-5 criteria for hypomania or mania
    Disease: Version SOC Term Classification Code Term Level
    19.1 10037175 - Psychiatric disorders 10000852 Acute mania LLT
    19.1 10037175 - Psychiatric disorders 10021030 Hypomania PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2010-023090-19 Sponsor Protocol Number: SMR 2375 Start Date*: 2011-03-29
    Sponsor Name:AlgiPharma AS
    Full Title: A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subje...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000748-41 Sponsor Protocol Number: 15/135763 Start Date*: 2015-09-03
    Sponsor Name:University of Exeter
    Full Title: Autoimmune Diabetes Accelerator Prevention Trial (adAPT)
    Medical condition: Children aged 5 to 16 on entry to the RCT with the presence of two or more islet-related autoantibodies which confers a 40% risk of developing type 1 diabetes in five years.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10036481 Pre-diabetes LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-016604-23 Sponsor Protocol Number: CACZ885I2207 Start Date*: 2010-05-03
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-center, double-blind, placebo-controlled, randomized study to compare the effect of a subcutaneous canakinumab administration to placebo in patients with Impaired Glucose Tolerance or patie...
    Medical condition: Impaired Glucose Tolerance and Type 2 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    12.0 10012594 Diabetes LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-012968-13 Sponsor Protocol Number: UCL08/0350 Start Date*: 2011-06-03
    Sponsor Name:University College London
    Full Title: A Proof of Principle, Double-Blind, Randomised Placebo-Controlled,Multi-centre Trial of pravaStatin to Ameliorate Early Onset Pre-eclampsia
    Medical condition: Pre-eclampsia
    Disease: Version SOC Term Classification Code Term Level
    16.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    16.1 10036585 - Pregnancy, puerperium and perinatal conditions 10040444 Severe pre-eclampsia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-023502-12 Sponsor Protocol Number: UCL 08/0350 Start Date*: Information not available in EudraCT
    Sponsor Name:University College London
    Full Title: A Proof of Principle, Double-Blind, Randomised Placebo-Controlled,Multi-centre Trial of pravaStatin to Ameliorate Early Onset Pre-eclampsia
    Medical condition: Pre-eclampsia
    Disease: Version SOC Term Classification Code Term Level
    10036485 Pre-eclampsia LLT
    10040444 Severe pre-eclampsia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2007-001454-77 Sponsor Protocol Number: VO57.07 Start Date*: 2007-09-12
    Sponsor Name:Stallergenes S.A
    Full Title: A randomised, double-blind, placebo-controlled, multi-national Phase II/III study of the safety and efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets o...
    Medical condition: House dust mite allergic rhinitis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001723 Allergic rhinitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) FR (Completed) DE (Completed) ES (Completed) NL (Completed) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-001998-15 Sponsor Protocol Number: TRIB–01–08 Start Date*: 2010-08-30
    Sponsor Name:SOPHARMA PLC
    Full Title: A phase IV, 16 weeks, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to assess the efficacy and safety of oral Tribulus terrestris (Tribestan®) in men with erectile dysfun...
    Medical condition: This Phase IV, 16 weeks study will be multicenter, randomized, double-blind, placebo-controlled. It will evaluate the efficacy and safety of Tribestan compared to placebo in men with erectile dysfu...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038604 - Reproductive system and breast disorders 10061461 Erectile dysfunction PT
    14.1 10037175 - Psychiatric disorders 10024419 Libido decreased PT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-001061-83 Sponsor Protocol Number: 2215-CL-0304 Start Date*: 2017-07-13
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with...
    Medical condition: FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) (FLT3/ITD) acute myeloid leukemia (AML) in first morphologic complete remission (CR1) that has been treated with allogeneic hem...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Temporarily Halted) GB (GB - no longer in EU/EEA) ES (Ongoing) BE (Completed) PL (Completed) DK (Completed) FR (Ongoing) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-002631-33 Sponsor Protocol Number: CAIN457A2209 Start Date*: 2009-01-14
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis
    Medical condition: Ankylosing Spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10002556 Ankylosing spondylitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-002502-74 Sponsor Protocol Number: NEU-01-02-01 Start Date*: 2012-02-14
    Sponsor Name:Neurophyxia B.V.
    Full Title: A multi-centre, randomised, double-blind, placebo-controlled Phase II study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of 2-iminobiotin (2-IB) in neonates with gestational...
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10004943 Birth asphyxia LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003500 Asphyxia neonatal LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) Outside EU/EEA
    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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