Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Dronedarone

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
     
    13 result(s) found for: Dronedarone. Displaying page 1 of 1.
    EudraCT Number: 2010-019247-19 Sponsor Protocol Number: DRONE_C_04629 Start Date*: 2010-10-12
    Sponsor Name:sanofi aventis groupe
    Full Title: A Randomized, international, multi-center, open-label study to document pharmacokinetics and optimal timing of initiation of dronedarone TreatmEnt following long-term aMIodarone in patients with pa...
    Medical condition: Paroxysmal or persistent atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) FR (Completed) DE (Completed) DK (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2010-019442-87 Sponsor Protocol Number: DROPPAF Start Date*: 2010-07-02
    Sponsor Name:East Sussex NHS Trust
    Full Title: Dronedarone in pacemaker patients with paroxysmal atrial fibrillation
    Medical condition: Paroxysmal atrial fibrillation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2005-000715-98 Sponsor Protocol Number: EFC5555 Start Date*: 2005-12-28
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A placebo-controlled, double blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with...
    Medical condition: atrial fibrillation/atrial flutter
    Disease: Version SOC Term Classification Code Term Level
    7.1 10003658 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) SE (Completed) FI (Completed) CZ (Completed) BE (Completed) NO (Completed) IT (Completed) PT (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-019791-73 Sponsor Protocol Number: EFC11405 Start Date*: 2010-07-22
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID on top of standard therapy in patients with permanent atrial fibrill...
    Medical condition: Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    14.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) SE (Prematurely Ended) FR (Prematurely Ended) CZ (Prematurely Ended) ES (Completed) HU (Completed) BE (Prematurely Ended) SK (Prematurely Ended) DK (Prematurely Ended) GB (Prematurely Ended) FI (Prematurely Ended) AT (Prematurely Ended) DE (Completed) IT (Prematurely Ended) PL (Prematurely Ended) BG (Prematurely Ended) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-005804-15 Sponsor Protocol Number: EFC4968 Start Date*: 2007-04-11
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: Randomized double blind trial to evaluate the efficacy and safety of dronedarone (400 mg BID) versus amiodarone (600 mg daily for 28 days then 200 mg daily thereafter) for at least 6 months for the...
    Medical condition: Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003658 Atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) SE (Completed) BE (Completed) FI (Completed) EE (Completed) AT (Completed) IT (Completed) NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-016818-24 Sponsor Protocol Number: DRONE_C_03668 Start Date*: 2010-08-26
    Sponsor Name:sanofi aventis
    Full Title: A Randomized, international, multi-center, open-label study to document optimal timing of initiation of dronedarone TreatmEnt after conversion with loading dose of aMIodarone in patients with perSi...
    Medical condition: Persistant atrial fibrillation requiring conversion of AF
    Disease: Version SOC Term Classification Code Term Level
    14.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) AT (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) EE (Prematurely Ended) FI (Completed) DE (Prematurely Ended) IT (Prematurely Ended) PT (Prematurely Ended) GR (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001134-42 Sponsor Protocol Number: GS-US-291-0102 Start Date*: 2012-05-22
    Sponsor Name:Gilead Sciences, Inc
    Full Title: A phase 2, proof of concept, randomised, placebo-controlled, parallel group study to evaluate the effect of ranolazine and dronedarone when given alone and in combination on atrial fibrillation bur...
    Medical condition: Paroxysmal Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004849 10034039 Paroxysmal atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-018215-53 Sponsor Protocol Number: AFRODITE Start Date*: 2010-02-10
    Sponsor Name:sanofi-aventis Netherlands
    Full Title: The effect of the addition of dronedarone to, versus increase of, existing conventional rate control medication on ventricular rate during paroxysmal or persistent atrial fibrillation (AFRODITE study)
    Medical condition: atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003658 Atrial fibrillation LLT
    12.1 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-018976-25 Sponsor Protocol Number: DRONE_L_05006 Start Date*: 2010-08-03
    Sponsor Name:sanofi-aventis Belgium
    Full Title: An open label non-controlled trial to evaluate the effect of dronedarone (Multaq® 400 mg BID) on the quality of life in patiënts with a history of, or current non-permanent atrial fibrillation (AF)
    Medical condition: Non permanent Atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003658 Atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004456-38 Sponsor Protocol Number: XEN-D0103-CL-05 Start Date*: 2014-04-11
    Sponsor Name:Xention Limited
    Full Title: A double blind, randomised, placebo-controlled, crossover study assessing the use of XEN D0103 in patients with paroxysmal atrial fibrillation and implanted pacemakers allowing continuous beat-to-b...
    Medical condition: Paroxysmal atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004849 10034039 Paroxysmal atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-004202-18 Sponsor Protocol Number: CRAFT Start Date*: 2018-01-30
    Sponsor Name:Fundación Interhospitalaria para la Investigación Cardiovascular
    Full Title: CRioablation vs Antiarrhythmic Drugs for Persistent Atrial Fibrillation Trial (CRAFT)
    Medical condition: Recurrent Persistent Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10071667 Persistent atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-002532-12 Sponsor Protocol Number: IDE:G050233 Start Date*: 2011-10-27
    Sponsor Name:MAYO CLINIC
    Full Title: Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)
    Medical condition: Atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021258-20 Sponsor Protocol Number: EAST Start Date*: 2011-06-15
    Sponsor Name:Kompetenznetz Vorhofflimmern e.V. (AFNET)
    Full Title: Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST)
    Medical condition: Atrial fibrillation, stroke, heart failure, myocardial infarction, cognitive dysfunction
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    20.0 10007541 - Cardiac disorders 10019280 Heart failures HLGT
    21.1 10029205 - Nervous system disorders 10061256 Ischaemic stroke PT
    20.0 10037175 - Psychiatric disorders 10009841 Cognitive and attention disorders and disturbances HLGT
    20.0 10007541 - Cardiac disorders 10028596 Myocardial infarction PT
    21.1 10029205 - Nervous system disorders 10019016 Haemorrhagic stroke PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed) NL (Completed) CZ (Completed) BE (Completed) ES (Completed) PL (Completed) IT (Ongoing)
    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-Mon May 05 14:38:59 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA