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Clinical trials for Drug holiday

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   44335   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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    11 result(s) found for: Drug holiday. Displaying page 1 of 1.
    EudraCT Number: 2006-003107-39 Sponsor Protocol Number: 0524A-023 Start Date*: Information not available in EudraCT
    Sponsor Name:Merck & Co
    Full Title: A Worldwide, Multicenter, Double-Blind, Randomized, Parallel Study to Evaluate the Efficacy of MK-0524 to Improve Tolerability of Extended Release Niacin
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000290-31 Sponsor Protocol Number: 2011.1.42 Start Date*: 2011-12-27
    Sponsor Name:Evangelisches Krankenhaus Lutherhaus gGmbH
    Full Title: Comparison of the effect of an ongoing treatment with alendronate or a drug holiday on the fracture risk in osteoporotic patients with a bisphosphonate long term therapy
    Medical condition: Osteoporosis (DXA-T-Score <-2,0 at lumbar spine, total hip or femur neck OR previous low trauma vertebral fractures) at high fracture risk
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005376-42 Sponsor Protocol Number: NN8828-3842 Start Date*: 2012-07-06
    Sponsor Name:Novo Nordisk A/S
    Full Title: A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) ES (Completed) HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-003285-26 Sponsor Protocol Number: ASTA Start Date*: Information not available in EudraCT
    Sponsor Name:Universität Mainz, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie
    Full Title: Effect of methylphenidate formulation on ADHD-patients' adherence to medical treatment. A comparison of Medikinet retard® (ER) once daily and Medikinet® (IR) twice daily in children and adolescents...
    Medical condition: Effect of methylphenidate formulation on ADHD-patients adherence to treatment
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-020836-21 Sponsor Protocol Number: NN8555-3797 Start Date*: 2011-01-07
    Sponsor Name:Novo Nordisk A/S
    Full Title: A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’...
    Medical condition: Crohn’s disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-000977-35 Sponsor Protocol Number: AtezoTRIBE Start Date*: 2018-09-13
    Sponsor Name:G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
    Full Title: Randomized phase II study of FOLFOXIRI plus BEVACIZUMAB plus ATEZOLIZUMAB versus FOLFOXIRI plus BEVACIZUMAB as first-line treatment of unresectable metastatic colorectal cancer patients
    Medical condition: Metastatic Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004438-40 Sponsor Protocol Number: GI1950 Start Date*: 2020-04-06
    Sponsor Name:Department of Oncology, Herlev & Gentofte Hospital
    Full Title: Phase 2 study in pretreated patients with advanced pancreatic cancer to assess efficacy of ipilimumab, nivolumab and tocilizumab in combination with radiation.
    Medical condition: Pretreated patients with advanced pancreatic cancer.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10033605 Pancreatic cancer metastatic LLT
    21.0 100000004864 10033606 Pancreatic cancer non-resectable LLT
    21.0 100000004864 10033607 Pancreatic cancer recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-003931-27 Sponsor Protocol Number: GI2118 Start Date*: 2021-10-20
    Sponsor Name:Department of Oncology, Herlev & Gentofte Hospital
    Full Title: Nivolumab, ipilimumab and radiation in combination with influenza vaccine in patients with pancreatic cancer.
    Medical condition: Metastatic pancreatic cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10033604 Pancreatic cancer LLT
    21.1 100000004864 10033605 Pancreatic cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002293-12 Sponsor Protocol Number: PCYC-1142-CA Start Date*: 2017-03-06
    Sponsor Name:Pharmacyclics LLC
    Full Title: Phase 2 study of the combination of ibrutinib plus venetoclax in subjects with treatment-naïve chronic lymphocytic leukemia / small lymphocytic lymphoma
    Medical condition: Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10008976 Chronic lymphocytic leukemia LLT
    19.0 100000004851 10003909 B-cell small lymphocytic lymphomas HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001359-36 Sponsor Protocol Number: CA223-001 Start Date*: 2016-07-26
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase I /II Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination with Anti-PD-1 (Nivolumab) in Advanced Refracto...
    Medical condition: Solid tumors
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) FR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-022983-11 Sponsor Protocol Number: BP25438 Start Date*: 2011-01-24
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A randomized, multicenter, open-label phase II study of RO5083945 in combination with FOLFIRI versus FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with KRAS wild-type...
    Medical condition: Metastatic colorectal cancer, KRAS wild-type (WT) or mutant, with disease progression after first line treatment with an oxaliplatin-containing regimen
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) FR (Completed) BE (Completed) DE (Completed) ES (Completed) IT (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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