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Clinical trials for FDC

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   44399   clinical trials with a EudraCT protocol, of which   7411   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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    169 result(s) found for: FDC. Displaying page 1 of 9.
    1  2  3  4  5  6  7  8  9  Next»
    EudraCT Number: 2013-003127-11 Sponsor Protocol Number: CQVA149A3401 Start Date*: 2014-02-26
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A prospective, multicenter, 12-week, randomized open-label study to evaluate the efficacy and safety of glycopyrronium (50 micrograms o.d.) or indacaterol maleate and glycopyrronium bromide fixed-d...
    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: CZ (Completed) LT (Completed) SK (Completed) BE (Completed) EE (Completed) LV (Completed) IE (Completed) SE (Completed) AT (Completed) PT (Completed) IT (Completed) GB (Completed) DK (Completed) GR (Completed) HU (Completed) PL (Completed) ES (Completed) DE (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2016-003016-12 Sponsor Protocol Number: TMC114FD2HTX1003 Start Date*: 2019-01-02
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A study to assess the acceptability/swallowability of DRV-containing FDC tablets in HIV-1 infected adolescents, using matching placebo tablets. Rezolsta: EMEA-001280-PIP01-12-M01 Decision: P/0...
    Medical condition: Human immunodeficiency virus (HIV) Type 1
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-000177-72 Sponsor Protocol Number: 208090 Start Date*: 2019-08-14
    Sponsor Name:ViiV Healthcare UK Limited
    Full Title: A Phase III, randomized, multicenter, open-label, non-inferiority study evaluating the efficacy, safety and tolerability of switching to dolutegravir/lamivudine fixed dose combination in HIV-1 infe...
    Medical condition: Human Immunodeficiency Virus-1 infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) DE (Completed) FR (Completed) DK (Completed) ES (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-001384-68 Sponsor Protocol Number: TMC114FD2HTX1006 Start Date*: 2019-09-19
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Study to Assess the Acceptability of Scored Film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Tablets in HIV-1 Infected Pediatric Parti...
    Medical condition: Human Immunodeficiency Virus Type 1
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2007-005107-17 Sponsor Protocol Number: 1184.15 Start Date*: 2008-01-28
    Sponsor Name:Boehringer Ingelheim bv
    Full Title: A 24-week (+ 24 week extension), randomized, placebo-controlled (only 1st 12-week period), double–blind, parallel-group, efficacy and safety comparison of Tiotropium/Salmeterol (7.5 µg/25 µg) Inhal...
    Medical condition: Moderate to severe COPD
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010952 COPD LLT
    9.1 10010953 COPD exacerbation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) ES (Completed) FI (Completed) DE (Prematurely Ended) PT (Prematurely Ended) BE (Completed) FR (Completed) SE (Prematurely Ended) DK (Prematurely Ended) LV (Prematurely Ended) HU (Prematurely Ended) LT (Prematurely Ended) EE (Prematurely Ended) GR (Prematurely Ended) IT (Prematurely Ended) AT (Prematurely Ended) SK (Completed)
    Trial results: View results
    EudraCT Number: 2016-002345-39 Sponsor Protocol Number: GS-US-380-1474 Start Date*: 2016-06-29
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infect...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2021-001641-13 Sponsor Protocol Number: CA224-098 Start Date*: 2022-01-11
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab +Relatlimab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma
    Medical condition: participants with completely resected Stage III or Stage IV melanoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) DK (Trial now transitioned) SE (Trial now transitioned) NO (Trial now transitioned) FI (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) GR (Trial now transitioned) PT (Completed) Outside EU/EEA RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-000454-31 Sponsor Protocol Number: CNA109586 Start Date*: 2007-07-04
    Sponsor Name:GlaxoSmithKline Research and Development Limited
    Full Title: Study of Once-Daily Abacavir/Lamivudine versus Tenofovir/Emtricitabine, Administered with Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects
    Medical condition: Antiretroviral-Naive, HIV-1 Infected Adults
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008922 Chronic infection with HIV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) BE (Completed) DE (Completed) GB (Completed) DK (Completed) LV (Completed) PT (Completed) AT (Completed) FR (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-005134-36 Sponsor Protocol Number: 1184.14 Start Date*: 2008-01-28
    Sponsor Name:Boehringer Ingelheim bv
    Full Title: A 24-week (+ 24 week extension), randomized, placebo-controlled (only 1st 12-week period), double–blind, parallel-group, efficacy and safety comparison of Tiotropium/Salmeterol (7.5 µg/25 µg) Inhal...
    Medical condition: Moderate to severe COPD
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010952 COPD LLT
    9.1 10010953 COPD exacerbation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) ES (Completed) FI (Completed) PT (Prematurely Ended) DE (Prematurely Ended) BE (Completed) DK (Completed) FR (Completed) SE (Prematurely Ended) IT (Prematurely Ended) LV (Prematurely Ended) GR (Completed) LT (Prematurely Ended) EE (Prematurely Ended) SK (Completed) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003428-61 Sponsor Protocol Number: GS-US-380-4449 Start Date*: 2018-04-06
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching from an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) ES (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000114-22 Sponsor Protocol Number: CQVA149A2316 Start Date*: 2015-09-02
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 26-week, randomized, double blind, parallel-group multicenter study to assess the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 μg o.d.) + salmeterol/fluticasone propionate FDC...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) EE (Completed) NL (Completed) LV (Completed) LT (Completed) DE (Completed) CZ (Completed) HU (Completed) DK (Completed) SK (Completed) ES (Completed) AT (Completed) PL (Completed) GR (Completed) HR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2018-000926-79 Sponsor Protocol Number: GS-US-380-4458 Start Date*: 2018-08-07
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide versus Dolutegravir + Emtricitabine/Tenofo...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection Hepatitis B Virus
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10068341 HIV-1 infection LLT
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) ES (Restarted) GR (Completed)
    Trial results: View results
    EudraCT Number: 2015-000754-38 Sponsor Protocol Number: TMC114FD2HTX3001 Start Date*: 2015-08-19
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Phase 3, randomized, active-controlled, double-blind study to evaluate efficacy and safety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once daily fixed dose combinatio...
    Medical condition: Human Immunodeficiency Virus Type 1
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) GB (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: 2015-004025-14 Sponsor Protocol Number: GS-US-380-1844 Start Date*: 2016-02-18
    Sponsor Name:Gilead Science, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of G...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-002346-33 Sponsor Protocol Number: MO43110 Start Date*: 2022-05-17
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IIIB, MULTINATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE PATIENT PREFERENCE FOR HOME ADMINISTRATION OF FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB FOR SUBCUTANEOU...
    Medical condition: Early or locally advanced/inflammatory HER2-positive (HER2+) breast cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) BG (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002918-41 Sponsor Protocol Number: IJB-EBC-Decrescendo-2020 Start Date*: 2021-08-25
    Sponsor Name:Institut Jules Bordet
    Full Title: De-Escalation of neoadjuvant ChemotheRapy in HER2-positive, EStrogen reCEptor-negative, Node-negative early breast cancer patients who achieved pathological complete response after neoadjuvant chem...
    Medical condition: HER2-positive, estrogen receptor (ER)-negative/progesterone receptor (PR)-negative, node-negative 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, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) IT (Prematurely Ended) IE (Completed)
    Trial results: View results
    EudraCT Number: 2006-005579-16 Sponsor Protocol Number: APV109141 Start Date*: 2007-04-13
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir, Administered with Abacavir/Lamivudine Once-Daily in Antiretroviral-Naïve HIV-1 Infected Adult Subjects.
    Medical condition: Treatment of HIV-1 infection.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008922 Chronic infection with HIV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) GB (Completed) FR (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004545-27 Sponsor Protocol Number: GS-US-366-1216 Start Date*: 2015-06-16
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positiv...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) GB (Completed) BE (Completed) ES (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001157-23 Sponsor Protocol Number: GO44096 Start Date*: 2023-01-03
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: A PHASE II, SINGLE-ARM, OPEN-LABEL STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS OF THE INTRAVENOUS FIXED-DOSE COMBINATION (IV FDC) OF TIRAGOLUMAB AND ATEZOLIZUMAB IN PARTICIPANTS WITH LOCALLY A...
    Medical condition: Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) CY (Trial now transitioned) ES (Ongoing) HR (Trial now transitioned)
    Trial results: (No results available)
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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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