Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Gadodiamide

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
     
    9 result(s) found for: Gadodiamide. Displaying page 1 of 1.
    EudraCT Number: 2009-011236-35 Sponsor Protocol Number: GE-041-075 Start Date*: 2009-10-13
    Sponsor Name:GE Healthcare Limited and its Affiliates
    Full Title: A post-marketing safety study in patients with moderate renal insufficiency who receive Omniscan (Gadodiamide Injection) for contrast enhanced magnetic resonance imaging (MRI) Estudio de seguridad...
    Medical condition: Patients with moderate renal insufficiency (estimated eGFR > 30 and <60 mL/min/1.73m2). Pacientes con insuficiencia renal moderada (tasa de filtración glomerular [TFG] >estimada 30 y <60 ml/min/1,...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064499 Nephrogenic fibrosing dermopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-000953-46 Sponsor Protocol Number: SOV301 Start Date*: 2004-10-13
    Sponsor Name:Amersham plc
    Full Title: A Multicentre, Phase 3, Open-Label, Controlled Study Evaluating the Efficacy and Safety of 0.1 mmol/kg Omniscan (Gadodiamide Injection) in Magnetic Resonance Angiography (MRA) of the Renal Arteries
    Medical condition: Renal artery stenosis (RAS) is implicated as the underlying cause in 1% to 5% of patients with hypertension and 5% to 15% of patients with end-stage renal disease entering dialysis programs each ye...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed)
    Trial results: View results
    EudraCT Number: 2004-000994-69 Sponsor Protocol Number: SOV302 Start Date*: 2004-11-11
    Sponsor Name:Amersham Buchler GmbH & Co KG an affiliate of GE Healthcare Bio-Sciences
    Full Title: A multicentre, phase 3, open label study to assess the efficacy and safety of 0.1 mmol/kg Omniscan™ (gadodiamide injection) for Magnetic Resonance Angiography (MRA) of the aorto-iliac arteries
    Medical condition: Suspected or proven chronic PAOD predominantly located in the aorto-iliac region of Fontaine Stages IIb to IV (ie, Rutherford Stages I3-III), or presents with an ankle brachial pressure index of <0...
    Disease: Version SOC Term Classification Code Term Level
    7.0 10062585 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023345-30 Sponsor Protocol Number: RAD-IPMT Start Date*: 2010-11-18
    Sponsor Name:U.L.S.S. 9 DI TREVISO
    Full Title: Prospective spontaneous cross-over study on pancreatic T1/T2 enhancement in patients with IPMT: comparison Omniscan-Dotarem
    Medical condition: Pancreatic intraductal papillary mucinous tumor
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004609 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-001680-33 Sponsor Protocol Number: MH-130 Start Date*: 2006-06-23
    Sponsor Name:BRACCO IMAGING
    Full Title: Phase IV, Double-blind, Multi-center, Randomized, Cross-over Study to Compare 0.10 mmol/kg of MultiHance R with 0.10 mmol/kg of Omniscan R in Magnetic Resonance Imaging MRI of the Brain
    Medical condition: patients sent to the sites with a request for assessment/diagnoses of certain/suspected brain neoplasms
    Disease: Version SOC Term Classification Code Term Level
    6.1 10029816 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-004207-11 Sponsor Protocol Number: Gd-NEPHRIC-01 Start Date*: 2006-01-03
    Sponsor Name:Malmö University Hospital, Dep of Radiology
    Full Title: Single blind study comparing nephrotoxicity in patients with decreased renal function after intravenous gadodiamide(Omniscan) or gadopenteate (Magnevist) injection in routine clinical Magnetic Reso...
    Medical condition: Patients with diabetes (type I or II) and impaired renal function defined as pre-study serum creatinine ≥150µmol/l if man and 133µmol/l if woman or an estimated prestudy glomerular filtration rate ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-001979-38 Sponsor Protocol Number: MultiH/BRA/711 (incl. Amendment #2) Start Date*: 2007-01-15
    Sponsor Name:Bracco Imaging Deutschland GmbH
    Full Title: INTRAINDIVIDUAL CROSS-OVER STUDY TO COMPARE MULTIHANCE® AND OMNISCAN® AT A DOSE OF 0.1 MMOL/KGBW IN THE DIFFERENTIAL DIAGNOSIS OF DISC HERNIATION VS. SCAR
    Medical condition: Intervertebral disc herniation
    Disease: Version SOC Term Classification Code Term Level
    8.1 10048856 Intervertebral disc herniation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001439-30 Sponsor Protocol Number: ALS-Gd64/001 Start Date*: 2013-03-22
    Sponsor Name:Navitas Life Sciences GmbH
    Full Title: Exploratory evaluation of the potential for long-term retention of Gadolinium in the bones of patients who have received Gadolinium based Contrast Agents according to their medical history.
    Medical condition: Retention of gadolinium/traces of metals/minerals to be determined in bone/skin specimens and evaluation of signs of nephrogenic systemic fibrosis in skin.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Prematurely Ended) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-002274-22 Sponsor Protocol Number: MH-127 Start Date*: 2006-12-18
    Sponsor Name:Bracco Imaging S.p.A.
    Full Title: A PHASE IIIB, DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE 0.1 MMOL/KG OF MULTIHANCE® WITH 0.1 MMOL/KG OF MAGNEVIST® FOR CONTRAST-ENHANCED MAGNETIC RESONANCE ANGIOGRAPHY (CE-...
    Medical condition: Subjects with moderate-to-severe peripheral arterial disease based on the Fontaine’s staging of peripheral arterial occlusive disease classes IIb, III and IV
    Disease: Version SOC Term Classification Code Term Level
    8.1 10062585 Peripheral arterial occlusive disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (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-Fri May 02 18:53:59 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA