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Clinical trials for Investigator's Brochure

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    25 result(s) found for: Investigator's Brochure. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2005-000808-14 Sponsor Protocol Number: AD-CT-01/05 Start Date*: 2005-05-24
    Sponsor Name:Ambria Dermatology
    Full Title: A randomized, double-blind, parallell-group, controlled study of topical pentane-1,5-diol hydrogel in patients with impetigo
    Medical condition: Impetigo
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004243-29 Sponsor Protocol Number: 27809 Start Date*: 2008-05-23
    Sponsor Name:Merck Serono International SA. An Affiliate of Merck KGaA, Darmstadt, Germany
    Full Title: A Phase IV open label study in moderate to severe chronic plaque psoriasis subjects transitioning from previous systemic antipsoriasis therapies (methotrexate, cyclosporine, retinoids or PUVA, NBUV...
    Medical condition: Adult subjects with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10037153 Psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-004033-42 Sponsor Protocol Number: MKI102428 Start Date*: 2007-11-22
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A 12-week, randomised, double-blind, placebo-controlled study to assess the anti-inflammatory activity, efficacy and safety of GW856553 in subjects with chronic obstructive pulmonary disease (COPD).
    Medical condition: Chronic obstructive pulmonary disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009033 Chronic obstructive pulmonary disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) DE (Completed) EE (Completed) FI (Completed) LT (Completed) SI (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-004681-55 Sponsor Protocol Number: 1100.1526 Start Date*: 2008-11-06
    Sponsor Name:Boehringer Ingelheim France
    Full Title: An open label, phase IIIb, randomized parallel group study to assess the efficacy and safety of switching HIV-1 infected patients successfully treated with a Nevirapine IR based regimen to Nevirapi...
    Medical condition: The patients for this trial are to be HIV-1 infected, antiretroviral treatment-experienced, currently receiving nevirapine IR 200 mg BID with a background therapy of fixed-dose combination (FDC) of...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-004774-27 Sponsor Protocol Number: ART108053 Start Date*: 2007-03-14
    Sponsor Name:GlaxoSmithKline Research & Development Ltd.
    Full Title: Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebO (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III...
    Medical condition: Superficial Thrombophlebitis (also known as superficial vein thrombosis)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10042557 Superficial thrombophlebitis of leg LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) EE (Completed) HU (Completed) LV (Completed) GR (Completed) FR (Completed) SK (Completed) CZ (Completed) IT (Completed) GB (Completed) BG (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-003774-29 Sponsor Protocol Number: Acute GvHD Start Date*: 2005-12-21
    Sponsor Name:Therakos, Inc.
    Full Title: A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy with Therakos "Uvadex" for the Treatment of Patients with Newly Diagnosed Acute Graft-Versus Host D...
    Medical condition: Graft-versus-Host Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) AT (Completed) BE (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-001642-17 Sponsor Protocol Number: AMB116457 Start Date*: 2013-04-26
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
    Medical condition: Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004855 10068739 Chronic thromboembolic pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) AT (Completed) DE (Completed) GB (Prematurely Ended) CZ (Prematurely Ended) NL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-004694-97 Sponsor Protocol Number: KG2105255 Start Date*: 2007-02-22
    Sponsor Name:GlaxoSmithKline Research & Development
    Full Title: A Phase IIb, 12-week, multicenter, randomized, double-blind, placebo-controlled, pioglitazone-controlled, parallel-group dose-ranging study in approximately 336 male and female subjects, aged 18 to...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    8.1 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) LV (Completed) CZ (Completed) BG (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-018780-42 Sponsor Protocol Number: OMB113676 Start Date*: 2010-10-28
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy
    Medical condition: Indolent B-Cell Non-Hodgkin's Lymphoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) CZ (Prematurely Ended) BG (Prematurely Ended) BE (Completed) FR (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2011-002827-17 Sponsor Protocol Number: ROP111662 Start Date*: 2013-04-23
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease.
    Medical condition: Early stage Parkinson's Disease.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2011-002828-41 Sponsor Protocol Number: ROP111569 Start Date*: 2013-04-23
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease.
    Medical condition: Advanced Parkinson's disease.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2017-001455-32 Sponsor Protocol Number: WIN001 Start Date*: 2017-12-15
    Sponsor Name:Worldwide Innovative Network Association
    Full Title: A proof of concept study to explore safety and efficacy of tri-therapy approach in advanced/metastatic NSCLC and retrospectively assess the ability of integrated genomics and transcriptomics to mat...
    Medical condition: Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (EGFR mutation, ALK translocation, ROS1 mutation if available or MET exon 14 skipping ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-000914-19 Sponsor Protocol Number: EPO-ANE-4008 Start Date*: 2006-10-23
    Sponsor Name:Janssen-Cilag International N.V., Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatme...
    Medical condition: Anemia in cancer patients receiving chemotherapy MedDRA Version 5.1 : list of preferred terma used in the process of defining thrombotic vascular events, see investigators brochure epoetin alpha.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Completed) SK (Completed) GR (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005244-95 Sponsor Protocol Number: ALA116402 Start Date*: 2012-06-27
    Sponsor Name:GlaxoSmithKline Research and Development Limited
    Full Title: A multi-national, randomized, double-blind, placebo-controlled, 3-period crossover study with GSK 573719 as monotherapy in adult subjects with asthma
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    15.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-002927-13 Sponsor Protocol Number: FIL_A-BEGEV Start Date*: 2022-03-22
    Sponsor Name:FONDAZIONE ITALIANA LINFOMI ONLUS
    Full Title: A phase I/II b (randomized controlled) study of atezolizumab combined to BEGEV regimen as first salvage treatment in patients with relapsed or refractory Hodgkin’s lymphoma candidate to autologous ...
    Medical condition: Refractory/relapsed Hodgkin Lymphoma.
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10020233 Hodgkin's disease mixed cellularity recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-005094-54 Sponsor Protocol Number: TPI ASM8-205 Start Date*: 2008-01-17
    Sponsor Name:Topigen Pharmaceuticals Inc.
    Full Title: A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 14-DAY INHALED TPI ASM8 IN SUBJECTS WITH ASTHMA
    Medical condition: allergic asthma and allergen-induced asthma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001705 Allergic asthma LLT
    9.1 10003638 Atopic asthma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000243-24 Sponsor Protocol Number: MD7114987 Start Date*: 2011-06-07
    Sponsor Name:GlaxoSmithKline Research & Development Ltd.
    Full Title: An open-label, phase 2a study to evaluate pazopanib eye drops administered for 12 weeks to patients with neovascular agerelated macular degeneration
    Medical condition: Age-related macular degeneration (AMD)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10015919 - Eye disorders 10025409 Macular degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000887-16 Sponsor Protocol Number: ICR-CTSU/2014/10044 Start Date*: 2014-11-07
    Sponsor Name:The Royal Marsden NHS Foundation Trust [...]
    1. The Royal Marsden NHS Foundation Trust
    2. The Institute of Cancer Research
    Full Title: A phase II randomised study evaluating the biological and clinical effects of the combination of palbociclib with letrozole as neoadjuvant therapy in post-menopausal women with ER+ primary breast c...
    Medical condition: ER positive, HER2 negative early invasive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-002250-24 Sponsor Protocol Number: GCAR-7213 Start Date*: 2021-12-07
    Sponsor Name:Global Coalition for Adaptive Research
    Full Title: GCAR-7213: GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Di...
    Medical condition: Oncology - Glioblastoma (GBM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) FR (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022777-34 Sponsor Protocol Number: RTG113413 Start Date*: 2011-02-01
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A Multicentre, Open-Label, Long-Term, Safety and Tolerability Study of Retigabine Immediate Release (IR) in Adults with Partial-Onset Seizures (Extension of Study RGB113905).
    Medical condition: Epilepsy - partial-onset seizures with or without secondary generalisation
    Disease: Version SOC Term Classification Code Term Level
    12.1 10065336 Partial epilepsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) IT (Completed) ES (Prematurely Ended) BG (Completed) BE (Completed) PL (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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