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Clinical trials for Mirabegron

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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    22 result(s) found for: Mirabegron. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2012-005735-91 Sponsor Protocol Number: 178-CL-101 Start Date*: 2013-11-12
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabeg...
    Medical condition: Overactive Bladder
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004857 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed) NL (Completed) CZ (Completed) HU (Completed) LV (Completed) SE (Completed) IT (Completed) EE (Completed) FI (Completed) SK (Completed) SI (Completed) DK (Completed) ES (Completed) LT (Completed) PL (Completed) GR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-001446-24 Sponsor Protocol Number: 178-CL-201 Start Date*: 2014-10-09
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Phase 1, Single Dose, 4-Period Crossover Study to Assess the Bioavailability of an Mirabegron Oral Suspension Relative to the Mirabegron Prolonged Release Tablet and to Assess the Effect of Food ...
    Medical condition: No medical indication will be investigated as only healthy subjects will be included.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004857 10059617 Overactive bladder LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-005736-29 Sponsor Protocol Number: 178-CL-102 Start Date*: 2014-07-08
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to S...
    Medical condition: Overactive Bladder
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004857 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) HU (Completed) IT (Completed) FI (Completed) GB (Completed) EE (Completed) SE (Completed) SK (Completed) CZ (Completed) LV (Completed) DK (Completed) SI (Completed) PL (Completed) ES (Completed) LT (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2010-020601-32 Sponsor Protocol Number: 178-CL-100 Start Date*: 2011-03-23
    Sponsor Name:Astellas Pharma Europe BV
    Full Title: A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of So...
    Medical condition: Overactive Bladder
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038359 - Renal and urinary disorders 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) GB (Completed) SE (Completed) FI (Completed) HU (Completed) CZ (Completed) DK (Completed) SK (Completed) PT (Completed) NO (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-000237-48 Sponsor Protocol Number: MiraBAT01 Start Date*: 2016-04-20
    Sponsor Name:Leiden University Medical Center
    Full Title: The effect of Mirabegron on brown adipose tissue in healthy young white Caucasian and South Asian men
    Medical condition: Obesity and dyslipidemia
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-002592-29 Sponsor Protocol Number: MIR-2014 Start Date*: 2015-04-17
    Sponsor Name:Fakultní nemocnice Ostrava
    Full Title: A randomized, double blind, placebo controlled study to evaluate the efficacy and safety of mirabegron 50 mg versus placebo in patients with neurogenic detrusor overactivity
    Medical condition: Spinal cord injury Multiple sclerosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005401-41 Sponsor Protocol Number: 905-EC-012 Start Date*: 2013-07-03
    Sponsor Name:Astellas Pharma Europe Ltd
    Full Title: A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects who have Received Solifenacin for 4 Weeks and Warr...
    Medical condition: Overactive Bladder
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004857 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) CZ (Completed) GB (Completed) SE (Completed) IE (Completed) BE (Completed) PT (Completed) NO (Completed) AT (Completed) FI (Completed) GR (Completed) HU (Completed) ES (Completed) SI (Completed) NL (Completed) DK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-001767-37 Sponsor Protocol Number: 178-CL-204 Start Date*: Information not available in EudraCT
    Sponsor Name:Astellas Pharma Global Development Inc.
    Full Title: A Phase 3, Double blind, Randomized, Multicenter, Parallel Group, Placebo controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Sub...
    Medical condition: Overactive bladder (OAB)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004857 10059617 Overactive bladder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) BE (Completed) NO (Completed) FR (Completed) DK (Completed) PL (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-005713-37 Sponsor Protocol Number: 178-EC-001 Start Date*: 2012-04-05
    Sponsor Name:Astellas Pharma Europe Ltd
    Full Title: A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects with Overactive Bladder (OAB) Treated with Antim...
    Medical condition: Overactive bladder
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038359 - Renal and urinary disorders 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) FI (Completed) CZ (Completed) SE (Completed) DE (Completed) ES (Completed) GB (Completed) SK (Completed) AT (Completed) BE (Completed) NO (Completed) GR (Completed) HU (Completed) DK (Completed) LV (Completed) NL (Completed) PT (Completed) PL (Completed) LT (Completed) SI (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000340-15 Sponsor Protocol Number: 178-CL-202 Start Date*: 2014-07-11
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A multicentre, open-label, single ascending dose Phase 1 study to evaluate the pharmacokinetics, safety and tolerability of mirabegron OCAS tablets in pediatric subjects from 5 to less than 18 year...
    Medical condition: -neurogenic detrusor overactivity (NDO) -overactive bladder (OAB)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004857 10012547 Detrusor hyperreflexia LLT
    16.1 100000004857 10059617 Overactive bladder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) NO (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-002876-25 Sponsor Protocol Number: 178-CL-206A Start Date*: 2016-03-30
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children...
    Medical condition: Neurogenic detrusor overactivity (NDO)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10012547 Detrusor hyperreflexia LLT
    20.0 100000004857 10059617 Overactive bladder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) LT (Completed) NO (Completed) BE (Completed) SK (Completed) RO (Completed) LV (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2015-000700-26 Sponsor Protocol Number: 178-CL-203 Start Date*: 2015-09-23
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A multicentre, open-label, single dose, phase 1 study to evaluate the pharmacokinetics, safety and tolerability of mirabegron oral suspension in pediatric subjects from 3 to less than 12 years of a...
    Medical condition: -neurogenic detrusor overactivity (NDO) -overactive bladder (OAB)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004857 10012547 Detrusor hyperreflexia LLT
    19.0 100000004857 10059617 Overactive bladder LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-002367-34 Sponsor Protocol Number: 29052016 Start Date*: 2016-09-30
    Sponsor Name:Hjertemedicinsk klinik, Rigshospitalet
    Full Title: Beta 3 agonist treatment in heart failure (BEAT-HF II)
    Medical condition: Heart Failure
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004849 10019279 Heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-005455-37 Sponsor Protocol Number: 178-CL-207 Start Date*: 2022-11-14
    Sponsor Name:Astellas Pharma Global Development Inc.
    Full Title: A Phase 3, Open Label, Multicenter, Baseline-Controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron P...
    Medical condition: Neurogenic detrusor overactivity (NDO)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10012547 Detrusor hyperreflexia LLT
    23.1 100000004857 10059617 Overactive bladder LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002949-32 Sponsor Protocol Number: SPHERE-HF Start Date*: 2017-03-22
    Sponsor Name:Fundació Clínic per la recerca Biomédica [...]
    1. Fundació Clínic per la recerca Biomédica
    2. CNIC
    Full Title: β3 adrenergic agoniSt treatment in chronic Pulmonary HypERtEnsion secondary to heart failure: a randomized placebo-controlled phase 2 clinical trial
    Medical condition: Pulmonary Hypertension secondary to heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2015-003146-75 Sponsor Protocol Number: BETA3_LVH Start Date*: 2016-03-14
    Sponsor Name:Université catholique de Louvain (UCL)
    Full Title: A multi-centre randomized, placebo-controlled trial of mirabegron, a new beta3-adrenergic receptor agonist on the progression of left ventricular mass and diastolic function in patients with struct...
    Medical condition: Structural heart disease at high risk for progressive hypertrophic cardiac remodeling at risk of developing HFpEF (heart failure with preserved ejection fraction).
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004849 10019290 Heart insufficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) PT (Completed) GR (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-004013-25 Sponsor Protocol Number: IMBE-01/2015 Start Date*: 2016-09-20
    Sponsor Name:Institute of Molecular Medicine and Biomedical Research- I.M.B.E.
    Full Title: Mirabegron in the management of lower urinary tract symptoms (LUTS) related to double-J (JJ) ureteral stents.
    Medical condition: Insertion of a JJ stent, prior to extracorporal shock wave lithotripsy (ESWL) and post ureterolithotripsy.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004857 10046707 Urolithiasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-004805-29 Sponsor Protocol Number: 201200480529 Start Date*: 2013-06-04
    Sponsor Name:The Heart Center, Rigshospitalet
    Full Title: Beta 3 agonist treatment in heart failure (BEAT-HF)
    Medical condition: Systolic heart failure
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004849 10019279 Heart failure LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004036-36 Sponsor Protocol Number: 178-MA-1008 Start Date*: 2016-07-18
    Sponsor Name:Astellas Pharma Global development, Inc
    Full Title: A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi- Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms While ...
    Medical condition: Over active bladder (OAB) in men with Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10046543 Urinary incontinence PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Completed) DE (Completed) PL (Completed) ES (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001451-19 Sponsor Protocol Number: 178-CL-046 Start Date*: 2008-06-05
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 (50 mg qd and 100 mg qd) in Subjects with ...
    Medical condition: Symptoms of Overactive Bladder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) SE (Completed) IS (Completed) CZ (Completed) LV (Completed) IE (Completed) GB (Completed) BE (Completed) FR (Completed) ES (Completed) HU (Completed) DK (Completed) LT (Completed) PT (Completed) IT (Completed) NL (Completed) AT (Completed) GR (Completed) SK (Completed) BG (Completed)
    Trial results: View results
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