Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Solifenacin

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   44346   clinical trials with a EudraCT protocol, of which   7374   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
     
    24 result(s) found for: Solifenacin. 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: 2005-005546-39 Sponsor Protocol Number: 905-EC-003 Start Date*: 2006-12-11
    Sponsor Name:Astellas Pharma Europe BV
    Full Title: SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN WITH SIMPLIFIED BLADDER TRAINING VERSUS SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN ALONE IN A PROSPECTIVE, RANDOMIZED, PARALLEL GROUP, OVERACT...
    Medical condition: Solifenacin succinate is indicated for the relief of symptoms of urinary frequency, nocturia and urgency with or without incontinence, associated with overactive bladder 10059617
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IE (Completed) HU (Completed) CZ (Completed) GB (Completed) DK (Completed) SE (Completed) IT (Completed) FI (Completed)
    Trial results: View results
    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: 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: 2006-002072-18 Sponsor Protocol Number: 905-CL-052 Start Date*: 2006-12-13
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A randomized, double-blind, parallel group, placebo controlled, multi center dose ranging study of solifenacin succinate (3 mg, 6 mg and 9 mg) in combination with tamsulosin OCAS 0.4 mg compared wi...
    Medical condition: Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Completed) CZ (Completed) DE (Completed) PT (Completed) SK (Completed) FI (Completed) HU (Completed) GB (Completed) BE (Completed) DK (Completed) FR (Completed) AT (Completed) SE (Completed) IT (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: 2008-001212-20 Sponsor Protocol Number: 905-CL-057 Start Date*: 2009-07-16
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: An open-label, long term multi-center study to assess the safety and efficacy of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg, in male ...
    Medical condition: Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038604 - Reproductive system and breast disorders 10004446 Benign prostatic hyperplasia PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Completed) AT (Completed) IT (Completed) DE (Completed) FR (Completed) HU (Completed) SK (Completed) BE (Completed) CZ (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-005523-42 Sponsor Protocol Number: 905-EC-005 Start Date*: 2007-09-05
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A randomized, double blind, double dummy, placebo controlled study to evaluate the efficacy and safety of solifenacin succinate (5 and 10mg once daily) against placebo and oxybutynin hydrochloride ...
    Medical condition: Neurogenic detrusor overactivity.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012547 Detrusor hyperreflexia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) NL (Completed) GB (Completed) HU (Completed) FR (Completed) DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-004296-22 Sponsor Protocol Number: 2014-RdC-PRO-Th Start Date*: 2015-11-10
    Sponsor Name:Centre Eugène Marquis
    Full Title: Anticholinergics impact in the treatment of acute irritative urinary toxicity during radiotherapy for prostate cancer
    Medical condition: Symptomatology related to acute urinary toxicity occuring during prostate irradiation in patients suffering from prostate cancer.
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004857 10004995 Bladder and urethral symptoms HLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Prematurely Ended)
    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: 2012-003178-22 Sponsor Protocol Number: 905-CL-074 Start Date*: 2013-04-17
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Phase 3, Open-Label, Baseline-controlled, Multi-center, Sequential Dose -Titration Study to Assess the Pharmacokinetics, Long-Term Efficacy and Safety of Solifenacin Succinate Suspension in Child...
    Medical condition: Neurogenic Detrusor Overactivity (NDO)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004857 10012547 Detrusor hyperreflexia LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) BE (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-001211-37 Sponsor Protocol Number: 905-CL-055 Start Date*: 2009-07-16
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A randomized, double-blind, parallel group, placebo controlled, multi-center study of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg and ...
    Medical condition: Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Completed) FR (Completed) SK (Completed) AT (Completed) BE (Completed) IT (Completed) DE (Completed) HU (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-001268-57 Sponsor Protocol Number: 905-CL-058 Start Date*: 2007-09-12
    Sponsor Name:Astellas Pharma US, Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate with 0.4 mg Tamsulosin Hydrochlo...
    Medical condition: Storage and Voiding Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027561 Micturition disorder LLT
    9.1 10005053 Bladder neck obstruction LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Completed) BE (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-017197-21 Sponsor Protocol Number: 905-CL-075 Start Date*: 2010-07-14
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A multicenter, open-label, single ascending dose study to evaluate pharmacokinetics, safety and tolerability of solifenacin succinate suspension in pediatric patients aged 5 to 17 years (inclusive)...
    Medical condition: Overactive bladder
    Disease: Version SOC Term Classification Code Term Level
    12.1 10059617 Overactive bladder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DK (Completed) SE (Completed) NO (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-005215-17 Sponsor Protocol Number: 905-EC-007 Start Date*: 2009-09-14
    Sponsor Name:Astellas Pharma Europe Limited
    Full Title: A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and urinary Nerve Growth Factor in Female Subjects with Overactive Bladder and a Diagnosis of Detrusor O...
    Medical condition: Overactive bladder
    Disease: Version SOC Term Classification Code Term Level
    12.0 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) ES (Completed) HU (Completed) CZ (Completed) DE (Completed) AT (Completed) SE (Completed) IT (Completed) SK (Completed) GB (Completed) BG (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-002047-10 Sponsor Protocol Number: 905-CL-077 Start Date*: 2012-11-01
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects with Overactive Bladder (OAB)
    Medical condition: Overactive Bladder (OAB)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004857 10059617 Overactive bladder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) NL (Completed) DE (Prematurely Ended) DK (Completed) SE (Completed) NO (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-000605-20 Sponsor Protocol Number: FFIS/2017/01/SLT Start Date*: 2017-07-26
    Sponsor Name:Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
    Full Title: PERIPHERAL TRANSCUTANEOUS NEUROMODULATION OF THE POST-TIBIAL NERVE (T-PTNS) FOR SOLIFENACIN 10mg. IN THE TREATMENT OF HYPERACTIVE BLADDER SYNDROME: NON-INFERIORITY PHASE IV RANDOMIZED CLINICAL TRIAL
    Medical condition: Overactive Bladder Syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000330-11 Sponsor Protocol Number: 905-CL-047 Start Date*: 2012-02-09
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in...
    Medical condition: Neurogenic Detrusor Overactivity (NDO)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004857 10012547 Detrusor hyperreflexia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) NL (Completed) DK (Completed) DE (Completed) FR (Ongoing) HU (Completed)
    Trial results: View results
    EudraCT Number: 2011-002066-20 Sponsor Protocol Number: 905-CL-076 Start Date*: 2012-11-01
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension ...
    Medical condition: Overactive Bladder
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004857 10059617 Overactive bladder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) NL (Completed) DE (Completed) SE (Completed) DK (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2012-003255-11 Sponsor Protocol Number: 191622-125 Start Date*: 2013-04-24
    Sponsor Name:Allergan Limited
    Full Title: A Study Evaluating the Efficacy and Safety of BOTOX® and Solifenacin in Patients with Overactive Bladder and Urinary Incontinence
    Medical condition: Overactive Bladder and Urinary Incontinence
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004857 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed) BE (Completed) PL (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.
    1  2  Next»
    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-Wed Jul 02 02:20:44 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA