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Clinical trials for Tolerability

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    14,030 result(s) found for: Tolerability. Displaying page 9 of 702.
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    EudraCT Number: 2010-019057-17 Sponsor Protocol Number: SPC3649-203 Start Date*: 2010-07-13
    Sponsor Name:Santaris Pharma A/S
    Full Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (miravirsen) Administered ...
    Medical condition: Patients infected with chronic hepatitis C
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) SK (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003310-14 Sponsor Protocol Number: SHO20190708 Start Date*: 2019-12-05
    Sponsor Name:Department of Dermatology, Bispebjerg Hospital
    Full Title: Laser immunotherapy with and without topical anti-PD1 in basal cell carcinomas
    Medical condition: Basal cell carcinoma in 24-30 patients
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-003482-25 Sponsor Protocol Number: CBYM338E2202 Start Date*: 2015-01-30
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A 28 week, randomized, double-blind, placebo-controlled, multi-center, parallel group dose range finding study to assess the effect of monthly doses of bimagrumab 70, 210, and 700 mg on skeletal mu...
    Medical condition: sarcopenia
    Disease: Version SOC Term Classification Code Term Level
    17.1 10028395 - Musculoskeletal and connective tissue disorders 10063024 Sarcopenia PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DK (Completed) BE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2018-003676-12 Sponsor Protocol Number: ATH3G10-006 Start Date*: 2018-12-17
    Sponsor Name:Athera Biotechnologies AB
    Full Title: A phase IIa, placebo-controlled, double blind, randomised multicentre pilot study to investigate the efficacy, safety and tolerability of the monoclonal antibody ATH3G10 in patients with ST-elevati...
    Medical condition: Treatment of ST-elevated myocardial infarction (STEMI) after percutaneous intervention (PCI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10007541 Cardiac disorders SOC
    20.0 10007541 - Cardiac disorders 10064346 STEMI LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2005-001224-36 Sponsor Protocol Number: A4021010 Start Date*: 2005-06-10
    Sponsor Name:Pfizer Inc. - Research & Development
    Full Title: Phase 1, Open Label, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-751,871 in Patients with Advanced Solid Tumours
    Medical condition: Advanced Solid Tumours
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2022-000922-46 Sponsor Protocol Number: GPBK-08/2018 Start Date*: 2023-01-27
    Sponsor Name:Dr. August Wolff GmbH & Co. KG Arzneimittel
    Full Title: An Open-Label, Uncontrolled, Multicenter Study to Evaluate the Safety, Local Tolerability, Systemic Exposure, and Efficacy of 1% GPB Cream in Adolescents With Severe Primary Axillary Hyperhidrosis ...
    Medical condition: Severe primary axillary hyperhidrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10020642 Hyperhidrosis PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2024-000583-38 Sponsor Protocol Number: 70033093THR1011 Start Date*: 2024-12-20
    Sponsor Name:Janssen Research & Development, LLC
    Full Title: Open-label, Multi-center, Single-dose Phase 1 Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Milvexian in Pediatric Patients From 28 Days to Less Than 18 Years of Age at Ris...
    Medical condition: Thromboembolic Events
    Disease: Version SOC Term Classification Code Term Level
    21.1 10047065 - Vascular disorders 10043565 Thromboembolic event LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2010-024485-21 Sponsor Protocol Number: daisy Start Date*: 2013-04-15
    Sponsor Name:FONDAZIONE TOSCANA GABRIELE MONASTERIO
    Full Title: Dipyridamole versus Adenosine infusion in the physiologic assessment of Intermediate coronary Stenoses in the cardiac catheterization laboratorY
    Medical condition: Patients with a single ≥ 50% e <75% coronary stenosis (visually extimated) at angiography, in one ore more coronary vessels).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001532-11 Sponsor Protocol Number: 01apr2014 Start Date*: 2014-09-11
    Sponsor Name:Ospedale San Raffaele
    Full Title: MONO-INSTITUTIONAL PHASE II TRIAL ADDRESSING TOLERABILITY AND ACTIVITY OF R-CHOP CHEMOIMMUNOTHERAPY PRECEDED BY BLOOD-BRAIN BARRIER PERMEABILIZATION BY NGR-TUMOR NECROSIS FACTOR IN PATIENTS WITH RE...
    Medical condition: Primary non-Hodgkin lymphoma in the central nervous system relapse / refractory
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003319-23 Sponsor Protocol Number: SLF_SCMO_0113 Start Date*: 2013-11-07
    Sponsor Name:Fondazione IRCCS Istituto Nazionale dei Tumori
    Full Title: SUBLINGUAL FENTANYL VERSUS SUBCUTANEOUS MORPHINE FOR THE MANAGEMENT OF SEVERE CANCER PAIN EPISODES IN PATIENTS ON OPIOID TREATMENT: A DOUBLE-BLIND RANDOMIZED NON–INFERIORITY TRIAL.
    Medical condition: pain due to cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004588-11 Sponsor Protocol Number: ABR64005 Start Date*: 2019-09-10
    Sponsor Name:University Maastricht
    Full Title: Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease.
    Medical condition: The chronic inflammatory bowel disease Crohn's disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002307-18 Sponsor Protocol Number: 2020-002307-18 Start Date*: 2021-02-10
    Sponsor Name:Oslo University Hospital
    Full Title: A phase IIa, double-blind, randomised, placebo-controlled study on the efficacy and tolerability of a 14-day treatment with teriflunomide 14 mg tablets vs. placebo in subjects with well-controlled ...
    Medical condition: Coeliac disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10009839 Coeliac disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005845-18 Sponsor Protocol Number: D7990C00004 Start Date*: 2021-06-24
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants with Hyperlipidaemia
    Medical condition: Hyperlipidaemia, evaluation of low-density lipoprotein cholesterol reduction and safety of AZD8233 vs. placebo
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10062060 Hyperlipidaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) DK (Completed) CZ (Completed) NL (Completed) HU (Completed) ES (Ongoing) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-013762-63 Sponsor Protocol Number: PRO044-CLIN-01 Start Date*: 2010-04-16
    Sponsor Name:Prosensa Therapeutics B.V
    Full Title: A phase I/IIa, open label, escalating dose, pilot study to assess the effect, safety, tolerability and pharmacokinetics of multiple subcutaneous doses of PRO044 in patients with Duchenne muscular d...
    Medical condition: Duchenne Muscular Dystrophy
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: NL (Completed) BE (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001499-12 Sponsor Protocol Number: BRF116013 Start Date*: 2013-04-22
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects with Advanced BRAF ...
    Medical condition: Advanced BRAF V600-Mutation Positive Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10049280 Solid tumour LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) Outside EU/EEA ES (Completed) DE (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004644-38 Sponsor Protocol Number: ID-078A303 Start Date*: 2018-10-30
    Sponsor Name:Idorsia Pharmaceuticals Ltd
    Full Title: Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension to studies ID-078A301 and ID-078A302 to assess the long term safety and tolerability of AC...
    Medical condition: Insomnia disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10022437 Insomnia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) FI (Completed) SE (Completed) DE (Completed) CZ (Completed) FR (Completed) HU (Completed) ES (Completed) BG (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002736-13 Sponsor Protocol Number: TV1106-IMM-30022 Start Date*: 2015-08-19
    Sponsor Name:Teva Pharmaceutical Industries Ltd.
    Full Title: A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-de...
    Medical condition: Growth hormone deficiency
    Disease: Version SOC Term Classification Code Term Level
    19.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Completed) SE (Prematurely Ended) IT (Prematurely Ended) AT (Completed) ES (Prematurely Ended) SI (Prematurely Ended) LT (Prematurely Ended) GR (Prematurely Ended) CZ (Prematurely Ended) PL (Prematurely Ended) SK (Prematurely Ended) HR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-014992-31 Sponsor Protocol Number: AC-065A303 Start Date*: 2010-02-22
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension
    Medical condition: The intended indication is Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) ES (Completed) SE (Completed) DK (Completed) GB (GB - no longer in EU/EEA) IE (Completed) PL (Completed) AT (Completed) HU (Completed) DE (Completed) SK (Completed) CZ (Completed) GR (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000402-29 Sponsor Protocol Number: GR41987 Start Date*: 2020-06-15
    Sponsor Name:F.Hoffmann La-Roche Ltd
    Full Title: A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA
    Medical condition: Diabetic Macular Edema (DME)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) CZ (Completed) DE (Completed) DK (Completed) HU (Completed) GB (GB - no longer in EU/EEA) SK (Completed) AT (Completed) PL (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003577-25 Sponsor Protocol Number: 1907V921F Start Date*: Information not available in EudraCT
    Sponsor Name:Shionogi B.V.
    Full Title: A Phase 1/2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment w...
    Medical condition: Opioid induced constipation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) HU (Prematurely Ended) IT (Completed) NL (Prematurely Ended) BE (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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