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Clinical trials for PDE5 inhibitors

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
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    • 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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    29 result(s) found for: PDE5 inhibitors. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2010-023586-22 Sponsor Protocol Number: BAY38-9456/12912 Start Date*: 2012-06-08
    Sponsor Name:Bayer AG
    Full Title: Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
    Medical condition: Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004150-85 Sponsor Protocol Number: HINEF: PDE5 Start Date*: 2008-04-11
    Sponsor Name:Charité Universitaetsmedizin Berlin
    Full Title: Cardiac failure with normal ejection fraction: possible role of phosphodiesterase type 5 inhibitors
    Medical condition: Patients with cradiac failure and normal ejection fraction
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-004222-17 Sponsor Protocol Number: H6D-MC-LVHX Start Date*: 2009-01-30
    Sponsor Name:Eli Lilly and Company Limited
    Full Title: A Randomized, Double-Blind, PLacebo-Controlled, Parallel Study to Assess the Efficacy and Safety of Tadalafil (LY450190) Once a Day in Subjects With Erectile Dysfunction Who Are Naive to PDE5 Inhib...
    Medical condition: Erectile dysfunction.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061461 Erectile dysfunction LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-004321-15 Sponsor Protocol Number: H6D-MC-LVHK(b) Start Date*: 2007-12-14
    Sponsor Name:Eli Lilly and Company Limited
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign P...
    Medical condition: Effects on urodynamic parameters in men with benign prostatic hyperplasia (also referred to as BPH-LUTS [lower urinary tract symptoms]) with and without urodynamic evidence of bladder outlet obstru...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004497-15 Sponsor Protocol Number: ERGO Start Date*: 2016-12-12
    Sponsor Name:UMBERTO I - POLICLINICO DI ROMA
    Full Title: Study on New Insights in Remodeling of Endocrine Cardiomyopathies: Intramyocardial, Molecular and Neuroendocrine Assessment in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A in C...
    Medical condition: Cushing’s Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10011652 Cushing's syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-004498-34 Sponsor Protocol Number: SUM Start Date*: 2016-12-12
    Sponsor Name:UMBERTO I - POLICLINICO DI ROMA
    Full Title: Study on New Insights in Remodeling of Endocrine Cardiomyopathies: ASsessmentt of Intramyocardial, Molecular and NeUroendocrine Parameters in Response to Chronic Inhibition of Cyclic GMP Phosphodie...
    Medical condition: Acromegaly
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10000599 Acromegaly PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-001055-21 Sponsor Protocol Number: H6D-CR-S024 Start Date*: 2008-07-30
    Sponsor Name:Eli Lilly and Company Limited
    Full Title: A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.
    Medical condition: Erectile Dysfunction
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052003 Erectile dysfunction NOS LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-011318-22 Sponsor Protocol Number: H6D-EW-LVIJ Start Date*: 2010-05-07
    Sponsor Name:Eli Lilly and Company Limited
    Full Title: Impact of Tadalafil (LY450190) Once a Day or Tadalafil On Demand Compared to Sildenafil Citrate On Demand on Treatment Discontinuation in Patients with Erectile Dysfunction who are Naïve to PDE5 In...
    Medical condition: Erectile Dysfunction
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038604 - Reproductive system and breast disorders 10061461 Erectile dysfunction PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) ES (Completed) FR (Completed) PT (Completed) GB (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2005-004648-30 Sponsor Protocol Number: A7771002 Start Date*: 2006-02-02
    Sponsor Name:Pfizer Limited
    Full Title: A randomized double blind, placebo controlled balanced 4-way crossover study to assess the efficacy of single oral doses of PF-00592379 on erectile function, using 100mg sildenafil as a positive co...
    Medical condition: Male Erectile Dysfunction (MED)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10052003 LLT
    Population Age: Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-001187-33 Sponsor Protocol Number: APD811-301 Start Date*: 2019-02-12
    Sponsor Name:Arena Pharmaceuticals, Inc.
    Full Title: A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients
    Medical condition: pulmonary arterial hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077731 Pulmonary hypertension WHO functional class I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) SE (Prematurely Ended) GB (GB - no longer in EU/EEA) HU (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) CZ (Trial now transitioned) BE (Trial now transitioned) BG (Trial now transitioned) NL (Trial now transitioned) GR (Trial now transitioned) PT (Trial now transitioned) IT (Trial now transitioned) HR (Completed) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-000077-39 Sponsor Protocol Number: RECOGITO_V1.0_2014 Start Date*: 2014-02-27
    Sponsor Name:Sapienza University of Rome
    Full Title: Study on New Insights in Remodeling of Diabetic Cardiomyopathy: Gender Difference in Intramyocardial, Molecular and Neuroendocrine Assessment in Response to Chronic Inhibition of Cyclic GMP Phospho...
    Medical condition: Diabetic Cardiomyopathy, Diabetes Mellitus Type 2, Left Ventricular Hypertrophy
    Disease: Version SOC Term Classification Code Term Level
    16.1 10007541 - Cardiac disorders 10049773 Left ventricular hypertrophy PT
    16.1 10007541 - Cardiac disorders 10012647 Diabetic cardiomyopathy PT
    16.1 10027433 - Metabolism and nutrition disorders 10012601 Diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-002841-21 Sponsor Protocol Number: H6D-MC-LVHJ(a) Start Date*: 2008-10-28
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of B...
    Medical condition: 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: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020122-18 Sponsor Protocol Number: BAY 98-7081/14694 Start Date*: 2010-07-23
    Sponsor Name:Bayer HealthCare AG
    Full Title: A prospective, randomized, double-blind, double-dummy, placebo- and active controlled, multicenter study assessing the efficacy and safety of the combination BAY 60 4552 / vardenafil compared to va...
    Medical condition: Erectile dysfunction
    Disease: Version SOC Term Classification Code Term Level
    12.1 10061461 Erectile dysfunction LLT
    Population Age: Adults Gender: Male
    Trial protocol: FR (Completed) DE (Completed) NL (Completed) FI (Completed) ES (Completed) IT (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2005-005060-92 Sponsor Protocol Number: 2-79-00500-002 Start Date*: 2006-09-01
    Sponsor Name:Ipsen Pharma GmBH
    Full Title: Phase IIIB, Double Blind, Placebo Controlled, International, Multicenter, Parallel Group Study, to Assess the Efficacy and Safety of Testim Gel in Combination with a Phosphodiesterase V Inhibitor (...
    Medical condition: To demonstrate that in patients with erectile dysfunction who have low or borderline baseline total testosterone levels, that Testim 50 mg Gel, indicated for male hypogonadism when testosterone def...
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended) BE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010739-42 Sponsor Protocol Number: H6D-MC-LVID Start Date*: 2009-10-01
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men with Signs ...
    Medical condition: 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: DE (Completed) NL (Completed) BE (Completed) AT (Completed) IT (Completed) FR (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2016-003417-95 Sponsor Protocol Number: 201247 Start Date*: 2017-01-13
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explo...
    Medical condition: Systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10028395 - Musculoskeletal and connective tissue disorders 10042953 Systemic sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-004815-29 Sponsor Protocol Number: ULA03 Start Date*: 2021-08-04
    Sponsor Name:Cardiorentis AG
    Full Title: Open-label, dose escalation study of ularitide for the investigation of hemodynamic effects in patients with pulmonary arterial hypertension (UPAH)
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-012057-38 Sponsor Protocol Number: CQTI571A2301 Start Date*: 2009-08-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arteria...
    Medical condition: Pulmonary arterial hypertension (PAH) patients who have a PVR ≥800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) ES (Completed) FR (Completed) SE (Completed) BE (Completed) IT (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-020604-29 Sponsor Protocol Number: H6D-CR-LVIW(a), Addendum 1 u.4 Start Date*: 2010-11-05
    Sponsor Name:Eli Lilly and Company Limited
    Full Title: A Phase 3b,randomized,double-blind,placebo-controlled parallel-design study to evaluate the efficacy and safety of tadalafil coadministered with finasteride for 6 months in men with lower urinary ...
    Medical condition: Benign Prostatic Hyperplasia (BPH)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10004446 Benign prostatic hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) FR (Completed) BE (Completed) IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2010-020220-22 Sponsor Protocol Number: H6D-MC-LVIR Start Date*: 2010-12-21
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effect of Tadalafil Once Daily for 8 Weeks on Prostatic Blood Flow and Perfusion Parameters in Men with Signs and Symptoms of Be...
    Medical condition: 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: BE (Completed) AT (Completed) IT (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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