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Clinical trials for Safety pharmacology

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   44334   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    88 result(s) found for: Safety pharmacology. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2006-004486-34 Sponsor Protocol Number: H6Q-MC-S001(a) Start Date*: 2006-10-18
    Sponsor Name:Eli Lilly and Company limited
    Full Title: An Open-Label Study of Oral Enzastaurin HCI in Patients with Advanced or Metastatic Malignancies
    Medical condition: Have a histologic or cytologic diagnosis of advanced or metastatic malignancies for which no life-prolonging therapy exists and have been previously enrolled and completed therapy in an enzastaurin...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2022-003581-20 Sponsor Protocol Number: ALPHA Start Date*: 2023-03-21
    Sponsor Name:Medical University Vienna
    Full Title: Albendazole pharmacokinetics in plasma, intra-cystic fluid, and cystic tissue of human cystic and alveolar echinococcosis
    Medical condition: Albendazole is an orally administered broad-spectrum anthelmintic Drug used in treatment of human alveolar and cystic echinococcosis. To date, data on albendazole and tissue pharmacokinetics are li...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-001956-40 Sponsor Protocol Number: PK_pregnancy Start Date*: 2023-03-05
    Sponsor Name:Medical University Vienna
    Full Title: Antibiotic pharmacokinetics in women with twin pregnancy
    Medical condition: The target population are twin pregnancy women that will deliver through c-section and that are receiving one or more of the included antibiotics.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-004914-79 Sponsor Protocol Number: CA017-003 Start Date*: 2016-10-22
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (BMS-936558, Anti-PD-1 Monoclonal Antibody) in Advanced Malignant Tumors
    Medical condition: Advanced Malignant Tumors
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) PL (Completed) NO (Completed) FI (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000465-17 Sponsor Protocol Number: CHL.3-02-2019 Start Date*: 2020-06-16
    Sponsor Name:Sintetica S.A.
    Full Title: A Phase II/III, Randomized, Double-Masked, Vehicle-Controlled, Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in healthy volunteers
    Medical condition: healthy volunteers
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10024758 Local anaesthesia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004391-11 Sponsor Protocol Number: RCC-DC-2011 Start Date*: 2012-02-08
    Sponsor Name:Masaryk University
    Full Title: Treatment of metastatic renal cell carcinoma using interleukin-12 secreting dendritic cells. Phase I/II clinical trial.
    Medical condition: Metatastic renal cell carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-008532-82 Sponsor Protocol Number: ARC1779-010b Start Date*: 2009-02-19
    Sponsor Name:Medical University of Vienna, Dept. of Clinical Pharmacology
    Full Title: A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B
    Medical condition: von Willebrand Disease type 2B
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000653-45 Sponsor Protocol Number: Fosfo1.0 Start Date*: 2018-04-27
    Sponsor Name:Department of Clinical Pharmacology, Medical University of Vienna
    Full Title: Pharmacokinetics of a novel extended infusion regimen of fosfomycin
    Medical condition: infections with fosfomycin-susceptible organisms e.g. bacteremia, soft tissue infections, central nervous system infections, endocarditis, abscesses etc.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-004686-34 Sponsor Protocol Number: Evaluation Statin Therapy Start Date*: 2007-02-27
    Sponsor Name:Karolinska University Hospital
    Full Title: Evaluation of Statin Therapy- Safety, Effect and Toxicity Mechanisms.
    Medical condition: Frequency of side effects in patients treated with HMG CoA reductase inhibitors.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10058108 Dyslipidaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000309-34 Sponsor Protocol Number: 7654321 Start Date*: 2016-06-10
    Sponsor Name:Medical University of Vienna
    Full Title: Vorapaxar in the human endotoxemia model
    Medical condition: LPS induced acute inflammatory state in healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2006-004222-93 Sponsor Protocol Number: GPE 02 Start Date*: 2006-11-28
    Sponsor Name:Curalogic A/S
    Full Title: Assessment of the Maximal Tolerated Dose of a Microencapsulated Grass (Phleum pratense) Pollen Extract (MGPE) in Subjects with Grass Pollen Allergy in a Randomized, Double-Blind, Placebo-Controlled...
    Medical condition: Treatment of seasonal allergic rhinitis to grass pollen.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003151-62 Sponsor Protocol Number: BENOS Start Date*: 2014-10-09
    Sponsor Name:Infectopharm Arzneimittel und Consilium GmbH
    Full Title: A randomised, two-period two-stage cross-over study on the relative bioavailability of two different formulations of single doses of noscapine (phase I/IV, open-label) in healthy volunteers (fasted...
    Medical condition: healthy subjects
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-000563-41 Sponsor Protocol Number: IMIMFTCL/GH/4 Start Date*: 2014-08-08
    Sponsor Name:Consorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)
    Full Title: Recombinant hGH Biomarkers Discovery
    Medical condition: Healthy volunteers. There is not intended indication.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002012-12 Sponsor Protocol Number: BENOS-2-L Start Date*: 2021-12-13
    Sponsor Name:InfectoPharm Arzneimittel und Consilium GmbH
    Full Title: A randomised, two-period two-stage cross-over study on the relative bioavailability of two different liquid formulations of single noscapine doses (phase I/IV, open-label) in healthy volunteers (fa...
    Medical condition: Healthy controls
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004163-12 Sponsor Protocol Number: RP2017-001 Start Date*: 2018-01-28
    Sponsor Name:ReposPharma
    Full Title: A phase 2a TDM-guided clinical study on the safety and efficacy of mebendazole in patients with advanced gastrointestinal cancer or cancer of unknown origin
    Medical condition: Squamous cell cancer or adenocarcinoma, including primary cancer of the liver, of the gastrointestinal tract or cancer of unknown origin
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10017985 Gastrointestinal neoplasm malignant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2019-000210-11 Sponsor Protocol Number: TMP-0315-2018 Start Date*: 2019-09-18
    Sponsor Name:Fraunhofer Gesellschaft for its Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
    Full Title: Prevention of Paclitaxel-induced neuropathic pain by Telmisartan in patients with planned Paclitaxel chemotherapy due to ovarian or breast cancer (PrevTel)
    Medical condition: patients with planned Paclitaxel chemotherapy due to ovarian or breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10077974 Peripheral neuropathic pain LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2023-000044-34 Sponsor Protocol Number: BT200-VWD2B Start Date*: 2024-08-14
    Sponsor Name:Medical University of Vienna, Department of Clinical Pharmacology
    Full Title: Efficacy and Safety of BT200 (rondoraptivon pegol) in Patients with Type 2B von Willebrand disease
    Medical condition: patients with type 2B Von Willebrand Disease with thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004108-16 Sponsor Protocol Number: HOFATA_v3.0 Start Date*: 2022-04-21
    Sponsor Name:Medical University Vienna
    Full Title: Host factors predicting target site concentration of antibiotics in critically ill patients: An explorative pharmacokinetic biomarker study
    Medical condition: All patients given standard of care intravenous therapy of the studied antibiotics will be screened against the inclusion criteria. Two groups are included: Group A (septic patients with organ dysf...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-024384-40 Sponsor Protocol Number: CCD-1015-PR-0055 Start Date*: 2011-04-28
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A single-dose, open-label, randomized, 2-way crossover, clinical pharmacology study of four inhalations of CHF 1535 100/6 NEXT DPI® (fixed combination of beclomethasone dipropionate 100μg plus form...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-004539-54 Sponsor Protocol Number: TMP-0731-2018 Start Date*: 2019-06-03
    Sponsor Name:Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP
    Full Title: Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients wit...
    Medical condition: Patients with active Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (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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