Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Prescription monitoring program

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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    5 result(s) found for: Prescription monitoring program. Displaying page 1 of 1.
    EudraCT Number: 2013-004816-22 Sponsor Protocol Number: CINC424A2407 Start Date*: 2014-05-30
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: The ReTreatment Trial: A phase II, open-label, single-arm study of re-treating myelofibrosis patients with ruxolitinib/Jakavi after treatment interruption due to loss of response and/or adverse event
    Medical condition: primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV MF)and post essential thrombocythemia vera (PETMF)
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) AT (Completed) DE (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001642-16 Sponsor Protocol Number: TAK-390MR_108 Start Date*: 2015-04-24
    Sponsor Name:Takeda Development Centre Europe Ltd.
    Full Title: A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 ...
    Medical condition: Acid-Related Disorders in Infants aged 1 to 11 months
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10066874 Gastroesophageal reflux disease LLT
    17.1 100000004856 10000479 Acid reflux (oesophageal) LLT
    17.1 100000004856 10019326 Heartburn LLT
    17.1 100000004856 10063657 Erosive esophagitis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Temporarily Halted) PL (Completed)
    Trial results: View results
    EudraCT Number: 2005-005023-33 Sponsor Protocol Number: 1182.99 Start Date*: 2007-03-15
    Sponsor Name:Boehringer Ingelheim France SAS
    Full Title: Safety and efficacy study of TPV boosted with low dose ritonavir (TPV/r) 500 mg/200 mg BID in antiretroviral treatment experienced HIV positive patients with HCV or HBV co-infection, with a pilot e...
    Medical condition: Treatment with three-class (NRTI, NNRTI, and PI) experienced HIV positive patients with HCV or HBV co-infection, with a minimum of 3-months duration for each class and have documented resistance to...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10020192 HIV-1 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) PT (Prematurely Ended) ES (Completed) DE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-005264-86 Sponsor Protocol Number: 1182.98 Start Date*: 2007-02-21
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir (TPV/r) 500 mg/200 mg BID IN a racially and Gender diverse HIV positive treatment experienced population with a p...
    Medical condition: The objective of this study is to demonstrate the safety and efficacy of TPV/r among a racially diverse HIV-positive population of females and males who are three-class (NRTI, NNRTI, and PI) experi...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-005365-35 Sponsor Protocol Number: 1449 Start Date*: 2008-07-20
    Sponsor Name:Fresenius Medical Care Deutschland GmbH
    Full Title: Multicentric, parallel, controlled, randomized, single blind clinical evaluation of a new low sodium peritoneal dialysis solution on patients with hypertension treated with continous ambulatory or...
    Medical condition: Subjects with renal failure treated with peritoneal dialysis
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004857 10009119 Chronic renal failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) FR (Completed) DK (Completed) GB (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed Apr 30 21:24:05 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA