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Clinical trials for Fixed-dose procedure

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   44336   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 ).  
     
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    45 result(s) found for: Fixed-dose procedure. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2017-004897-32 Sponsor Protocol Number: WO40324 Start Date*: 2018-06-04
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A phase III, randomized, multicenter, open-label, two-arm study to evaluate the pharmacokinetics, efficacy, and safety of subcutaneous administration of the fixed-dose combination of pertuzumab and...
    Medical condition: Human epidermal growth factor receptor 2 (HER2)-positive Early Breast Cancer.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Ongoing) BE (Completed) CZ (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002153-30 Sponsor Protocol Number: MO40628 Start Date*: 2018-10-24
    Sponsor Name:Roche Farma S.A.(Soc Uni) que realiza el ensayo en España y que actúa como representante de F. Hoffmann-La Roche Ltd.
    Full Title: A randomized, multicenter, open-label cross-over study to evaluate patient preference and satisfaction of subcutaneous administration of the fixed-dose combination of pertuzumab and trastuzumab in ...
    Medical condition: Human epidermal growth factor receptor 2 (HER2)-positive Early Breast Cancer.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) PT (Completed) SE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2020-004241-36 Sponsor Protocol Number: ML42502 Start Date*: 2021-03-23
    Sponsor Name:Roche Farma S.A
    Full Title: TIME AND MOTION STUDY OF A SUBCUTANEOUS FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB FOR THE TREATMENT OF PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER.
    Medical condition: EARLY BREAST CANCER
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER2 positive breast cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-008260-28 Sponsor Protocol Number: TAK-491CLD_308 Start Date*: 2010-02-03
    Sponsor Name:Takeda Global Research & Development Centre (Europe) Ltd.
    Full Title: A Phase 3, Open-Label, Randomized, Long-Term Comparison of the Safety and Tolerability of the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs. Olmesartan Medoxomil-Hydrochlorothiazide Fixed-D...
    Medical condition: TAK-491CLD is being evaluated to treat essential hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015488 Essential hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-004218-28 Sponsor Protocol Number: TAK-491CLD_302 Start Date*: 2009-11-26
    Sponsor Name:Takeda Global Research & Development Centre (Europe) Ltd.
    Full Title: A Phase 3, Double-Blind, Randomized, Factorial, Efficacy and Safety Study of TAK 491 Plus Chlorthalidone Fixed-Dose Combination in Subjects with Moderate to Severe Hypertension
    Medical condition: TAK-491CLD is being evaluated to treat moderate to severe essential hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015488 Essential hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-001530-40 Sponsor Protocol Number: HEC WST06 1276N/WST 2.24 Start Date*: 2006-07-18
    Sponsor Name:STEBA FRANCE
    Full Title: Vascular targeted photodynamic therapy using WST09 for patients with untreated localised prostate cancer - Repeat procedure – Phase IIa, Single centre, open-label study.
    Medical condition: Localised Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    10036921
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-002784-27 Sponsor Protocol Number: Stei-Azurcomp-0107 Start Date*: 2008-01-18
    Sponsor Name:Steiner & Co. Deutsche Arzneimittelgesellschaft mbH & Co. KG
    Full Title: Randomised, double-blind, prospective multi-centre study to compare the analgesic efficacy and safety of a paracetamol/codeine/caffeine fixed-dose combination (Azur® compositum) with paracetamol/co...
    Medical condition: Post-operative pain after a dental surgical procedure (third molar surgery).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10054711 Postoperative pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2023-000362-34 Sponsor Protocol Number: SAN-0791 Start Date*: 2023-10-12
    Sponsor Name:Lek Pharmaceuticals d.d.
    Full Title: An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in A...
    Medical condition: Seasonal Allergic Rhinitis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-005318-50 Sponsor Protocol Number: M-40464-33 Start Date*: 2015-05-04
    Sponsor Name:AstraZeneca AB; Karlebyhus, Astraallén, Södertälje SE-151 85, Sweden
    Full Title: A MULTIPLE DOSE, RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL CLINICAL TRIAL TO ASSESS THE EFFECT OF ACLIDINIUM BROMIDE/FORMOTEROL FUMARATE FIXED-DOSE COMBINATION ON LUNG HYPERINFLATION, ...
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-004285-35 Sponsor Protocol Number: CA224-123 Start Date*: 2022-07-12
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Open-label (Sponsor Blinded) Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants with Later-lines o...
    Medical condition: Metastatic Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) NL (Trial now transitioned) CZ (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003823-31 Sponsor Protocol Number: AG348-C-006 Start Date*: 2019-04-08
    Sponsor Name:Agios Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency
    Medical condition: Pyruvate Kinase Deficiency
    Disease: Version SOC Term Classification Code Term Level
    21.1 10010331 - Congenital, familial and genetic disorders 10037682 Pyruvate kinase deficiency anaemia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) FR (Completed) PT (Completed) ES (Completed) DK (Completed) NL (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-001719-21 Sponsor Protocol Number: 1237-0095 Start Date*: 2019-12-23
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A randomized, double blind, placebo-controlled, multi-center, parallel group study to compare the efficacy of inhaled tiotropium + olodaterol, fixed dose combination (5μg/5μg) vs. placebo delivered...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001800-74 Sponsor Protocol Number: NEPA-15-18 Start Date*: 2015-08-17
    Sponsor Name:Helsinn Healthcare SA
    Full Title: A phase 3, multicenter, randomized, double-blind, active control study to evaluate the safety and efficacy of IV pro-netupitant/palonosetron (260 mg/0.25 mg) combination for the prevention of chemo...
    Medical condition: nausea and vomiting in cancer patients receiving highly emetogenic therapy
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10036899 Prophylaxis against chemotherapy induced vomiting LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) CZ (Completed) ES (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2009-016278-34 Sponsor Protocol Number: 24189 Start Date*: 2010-05-12
    Sponsor Name:Imperial College London
    Full Title: UMPIRE - Use of a Multidrug Pill In Reducing cv Events a randomised controlled trial of fixed dose combination medication and usual care in those at high risk of cardiovascular disease.
    Medical condition: Cardiovascular disease subjects either with established disease or at high risk
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-016775-30 Sponsor Protocol Number: NETU-08-18 Start Date*: 2011-02-24
    Sponsor Name:Helsinn Healthcare SA
    Full Title: A phase III multicenter, randomized, double-blind, double-dummy, active-controlled, parallel group study of the efficacy and safety of oral netupitant administered in combination with palonosetron ...
    Medical condition: Nausea and vomiting in cancer patients receiving moderately emetogenic theraphy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10054133 Prophylaxis of nausea and vomiting PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) PL (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-002810-20 Sponsor Protocol Number: D356FC00003 Start Date*: 2007-09-13
    Sponsor Name:AstraZeneca AB
    Full Title: A 12-week Open-Label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to compare the Efficacy and Safety of rosuvastatin (CRESTOR) 10 mg and 20 mg in Combination with Ezetimibe 10 mg and ...
    Medical condition: Dyslipidemia - Expert groups have identified low-density lipoprotein cholesterol (LDL-C) as the primary target for cholesterol lowering therapy because it is strongly associated with coronary heart...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058110 Dyslipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2010-021215-16 Sponsor Protocol Number: H9P-MC-LNBQ Start Date*: 2011-02-17
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 12 mg to 18 mg Once Daily and LY2216684 Fixed-Dose 6 mg Once Daily as Adjunctive Treatment for Patients with Major De...
    Medical condition: Major depressive disorder (MDD)
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004873 10025453 Major depressive disorder NOS LLT
    Population Age: Gender: Male, Female
    Trial protocol: CZ (Completed) FI (Completed) SK (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2005-000319-87 Sponsor Protocol Number: NN304-1657 Start Date*: 2005-08-03
    Sponsor Name:Novo Nordisk Pharma GmbH
    Full Title: A 52 week, Open Labelled, Randomised multi-centre 2 Arm Parallel Group Trial comparing Efficacy and Safety of Insulin Aspart, given in a Fixed Dose Regimen or in a Flexible Regimen, with or without...
    Medical condition: Type II diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    8.0 10045242 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004392-41 Sponsor Protocol Number: MK-1439A-054 Start Date*: 2016-11-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Study of the Comparative Bioavailability of Two Investigational Pediatric Oral Granule Formulations of Lamivudine and Tenofovir Compared to the Adult Marketed Formulations. Other PIP decision ...
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-005627-17 Sponsor Protocol Number: TR03 Start Date*: 2015-12-01
    Sponsor Name:Trevi Therapeutics, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCL ER Tablets in Prurigo Nodularis Patients
    Medical condition: Prurigo Nodularis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10040785 - Skin and subcutaneous tissue disorders 10040785 Skin and subcutaneous tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) AT (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
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