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Clinical trials for ANDA

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.
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    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.
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    33 result(s) found for: ANDA. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2016-002601-19 Sponsor Protocol Number: OND-URG Start Date*: 2019-09-16
    Sponsor Name:Basque Health Service
    Full Title: Effectiviness and safety of the administration of ondansetron versus placebo for the treatment of vomit in children with mild and moderate dehydration: randomized clinical trial
    Medical condition: Vomiting
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-004761-34 Sponsor Protocol Number: 150-CL-012 Start Date*: 2007-04-19
    Sponsor Name:Astellas US Pharma US Inc.(APUS)
    Full Title: A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability and Pharmacodynamics of YM150 in Subjects with Non-Valvular Atrial Fibrillation.
    Medical condition: Prevention of stroke on patients with Non-Valvular Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    8.1 10049165 Cerebrovascular accident prophylaxis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-001324-34 Sponsor Protocol Number: C-12-008 Start Date*: 2013-03-07
    Sponsor Name:Alcon Research Ltd
    Full Title: A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
    Medical condition: Pediatric glaucoma;elevated intraocular pressure
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) PL (Completed) DE (Completed) PT (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-000220-33 Sponsor Protocol Number: CLCZ696BDE03 Start Date*: 2019-02-04
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A randomized, double-blind, active-controlled study to assess the effect of sacubitril/valsartan compared with enalapril to improve erectile function in patients with heart failure with reduced eje...
    Medical condition: Patients with heart failure with reduced ejection fraction (HFrEF) and erectile dysfunction (ED)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10008502 CHF LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-005760-99 Sponsor Protocol Number: SPD426-405 Start Date*: 2013-05-30
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 4, Randomized-withdrawal, Double-blind, Placebo controlled, Parallel-group Study to Investigate the Clinical Benefit of Midodrine Hydrochloride in Male and Female Subjects with Symptomatic ...
    Medical condition: Symptomatic orthostatic hypotension (SOH)
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004866 10021102 Hypotension orthostatic symptomatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-004632-35 Sponsor Protocol Number: CLCZ696BDE01 Start Date*: 2016-05-04
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A randomized, double-blind, active-controlled study to assess the effect of LCZ696 compared with enalapril to improve exercise capacity in patients with heart failure with reduced ejection fraction...
    Medical condition: chronic heart failure and reduced ejection fraction
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10008502 CHF LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-005761-12 Sponsor Protocol Number: SPD426-406 Start Date*: 2013-05-06
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 4, Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Clinical Benefit of Midodrine Hydrochloride in Male and Female Subjects with Symptomatic Orthostatic Hypo...
    Medical condition: Symptomatic orthostatic hypotension (SOH)
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004866 10021102 Hypotension orthostatic symptomatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: View results
    EudraCT Number: 2017-002283-41 Sponsor Protocol Number: 151032-002 Start Date*: 2017-09-11
    Sponsor Name:HRA Pharma
    Full Title: A prospective, randomized, parallel-group study to assess the effects on ovarian activity of ellaOne (ulipristal acetate 30 mg single dose) taken after three consecutive days of missed combined ora...
    Medical condition: Emergency contraception
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002668-28 Sponsor Protocol Number: HP-301 Start Date*: 2020-04-21
    Sponsor Name:Phathom Pharmaceuticals, Inc.
    Full Title: A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy with Oral Vonoprazan 20 mg or Double-Blind Triple Therapy with Oral Vonoprazan 20 mg Compared t...
    Medical condition: Helicobacter pylori infection
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004862 10019377 Helicobacter pylori infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-000427-41 Sponsor Protocol Number: CPPFAP-310 Start Date*: 2014-05-15
    Sponsor Name:Cancer Prevention Pharmaceuticals, Inc.
    Full Title: A Double-Blind, Randomized, Phase III Trial of the Safety and Efficacy of CPP-1X/Sulindac Compared With CPP-1X, Sulindac as Single Agents in Patients with Familial Adenomatous Polyposis (FAP)
    Medical condition: Familial Adenomatous Polyposis (FAP)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) NL (Completed) ES (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-003367-26 Sponsor Protocol Number: MK4482-001 Start Date*: 2020-11-18
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults with COVID-19
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084382 Coronavirus disease 2019 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (GB - no longer in EU/EEA) SE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-003202-82 Sponsor Protocol Number: MK7655A-016 Start Date*: 2019-07-09
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Pip...
    Medical condition: Hospital-Acquired Bacterial Pneumonia / Ventilator-Associated Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-003812-10 Sponsor Protocol Number: PHP-ICC-203 Start Date*: 2017-08-29
    Sponsor Name:Delcath Systems Inc.
    Full Title: A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Stand...
    Medical condition: Intrahepatic cholangiocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10073077 Intrahepatic cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-003600-20 Sponsor Protocol Number: MK-0431E-211 Start Date*: 2012-08-02
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Co-Administration of Sitagliptin and Atorvastatin in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Co...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    15.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002101-35 Sponsor Protocol Number: HyperCarD2 Start Date*: 2017-08-24
    Sponsor Name:Sten Madsbad
    Full Title: THE ROLE OF HYPERGLYCEMIA, HYPERINSULINEMIA AND ELEVATED FREE FATTY ACIDS FOR CARDIAC FUNCTION IN PATIENTS WITH TYPE 2 DIABETES – THE HYPERCARD2 STUDY
    Medical condition: typé 2 diabetes
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004729-16 Sponsor Protocol Number: 1263-301 Start Date*: 2008-01-25
    Sponsor Name:ViroPharma Incorporated
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR VERSUS ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECE...
    Medical condition: Main purpose is to assess the efficacy and safety of prophylactic use of oral Maribavir versus oral Ganciclovir to prevent cytomegalovirus disease in recipients of orthotopic liver transplants at h...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009701 CMV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) FR (Completed) GB (Prematurely Ended) AT (Completed) DE (Completed) BE (Completed) ES (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-013269-24 Sponsor Protocol Number: 1268.41 Start Date*: Information not available in EudraCT
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: Randomised, double-blind, triple dummy, partial cross-over (each active treatment with placebo) study using an Environmental Challenge Chamber (ECC) to assess the safety and efficacy of 2 weeks of ...
    Medical condition: Allergic rhinitis due to pollen
    Disease: Version SOC Term Classification Code Term Level
    12.0 10001726 Allergic rhinitis due to pollen LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-004156-37 Sponsor Protocol Number: ND0612-317 Start Date*: 2020-05-18
    Sponsor Name:NeuroDerm Ltd.
    Full Title: A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infus...
    Medical condition: Parkinson's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing) GB (GB - no longer in EU/EEA) CZ (Trial now transitioned) FR (Trial now transitioned) HU (Prematurely Ended) AT (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned) NL (Ongoing) SK (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000417-73 Sponsor Protocol Number: GS-US-342-2097 Start Date*: 2016-07-11
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subje...
    Medical condition: Chronic Hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    19.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-003066-10 Sponsor Protocol Number: GS-US-342-4022 Start Date*: 2017-05-02
    Sponsor Name:Gilead Sciences International Ltd.
    Full Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects with Chronic HCV Infection and C...
    Medical condition: Chronic hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    20.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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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