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Clinical trials for Riociguat

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   44334   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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    31 result(s) found for: Riociguat. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2012-002104-40 Sponsor Protocol Number: BAY63-2521/16097 Start Date*: 2013-03-14
    Sponsor Name:Bayer HealthCare AG
    Full Title: An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in ...
    Medical condition: Chronic Trombo Embolic Pulmonary Hypertention
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004855 10068740 CTEPH LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) PT (Completed) ES (Completed) BE (Completed) CZ (Completed) DK (Completed) NL (Completed) IT (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-001759-10 Sponsor Protocol Number: Bay63-2521/16719 Start Date*: 2014-01-03
    Sponsor Name:Bayer AG
    Full Title: Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to tr...
    Medical condition: Hypertension, Pulmonary
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) IT (Completed) BE (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-001121-40 Sponsor Protocol Number: PEA_Bridging_Study Start Date*: 2018-09-17
    Sponsor Name:International CTEPH Association (ICA)
    Full Title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High P...
    Medical condition: Chronic Thromboembolic Pulmonary Disease (CTEPH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10068740 CTEPH LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000501-36 Sponsor Protocol Number: BAY63-2521/18694 Start Date*: 2016-06-09
    Sponsor Name:Bayer HealthCare
    Full Title: An open-label, multi-national, multi-center, single-arm, uncontrolled, long-term extension study of orally administered riociguat in patients with symptomatic pulmonary arterial hypertension (PAH) ...
    Medical condition: Hypertension, Pulmonary
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-003952-29 Sponsor Protocol Number: BAY63-2521/15681 Start Date*: 2015-08-25
    Sponsor Name:Bayer AG
    Full Title: Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (...
    Medical condition: Hypertension, Pulmonary
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) IT (Trial now transitioned) GB (Completed) DE (Trial now transitioned) ES (Prematurely Ended) PL (Completed) Outside EU/EEA BE (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2010-024332-42 Sponsor Protocol Number: BAY63-2521/13605 Start Date*: 2014-04-10
    Sponsor Name:Bayer HealthCare AG
    Full Title: A randomized, double-blind, placebo-controlled phase II study to investigate the efficacy and safety of riociguat (0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID) in patients with symptomatic pulmon...
    Medical condition: pulmonary hypertension associated with idiopathic interstitial pneumonias
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004855 10037406 Pulmonary hypertension secondary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Completed) ES (Completed) BE (Completed) GB (Completed) PT (Completed) DK (Completed) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003055-60 Sponsor Protocol Number: RIO-40400 Start Date*: 2014-10-10
    Sponsor Name:Medical University of Vienna
    Full Title: Evaluation of the pharmacodynamic effects of riociguat in subjects with pulmonary hypertension and heart failure with preserved ejection fraction in a randomized, double blind, placebo controlled, ...
    Medical condition: Pulmonary hypertension and heart failure with preserved ejection fraction
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001067-36 Sponsor Protocol Number: 18588 Start Date*: 2016-11-21
    Sponsor Name:Bayer AG
    Full Title: A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosp...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) PT (Completed) AT (Completed) CZ (Completed) GB (Completed) DE (Completed) BE (Completed) NL (Completed) DK (Completed) GR (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-018436-41 Sponsor Protocol Number: Bay 63-2521/14554 Start Date*: 2010-05-11
    Sponsor Name:Bayer HealthCare AG
    Full Title: Acute hemoDynamic effects of RIociguat (BAY 63-2521) in patients with puLmonary hypertension Associated with diasTolic heart failurE (DILATE 1): A randomized, double-blind, placebo-controlled, sin...
    Medical condition: Pulmonary hypertension associated with diastolic heart failure
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037405 Pulmonary hypertension primary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) CZ (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-003928-37 Sponsor Protocol Number: BAY63-2521/12916 Start Date*: 2008-07-14
    Sponsor Name:Bayer AG
    Full Title: A multicenter, non-randomized, non-blinded, non-controlled study to investigate the impact of multiple doses of BAY 63-2521 on safety, tolerability, pharmacokinetics and pharmacodynamics in patient...
    Medical condition: Patients with interstitial lung disease associated pulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001633-40 Sponsor Protocol Number: ESRA Start Date*: 2022-03-07
    Sponsor Name:Thoraxklinik Heidelberg gGmbH
    Full Title: Efficacy and safety of riociguat (MK-4836) in incipient pulmonary vascular disease as an indicator for early pulmonary arterial Hypertension Doubleblind, randomized, multicentre, multinational, pla...
    Medical condition: early pulmonary vascular disease, defined as either a) mean pulmonary arterial pressure (mPAP) ≥25 mmHg with pulmonary vascular resistance (PVR) ≥2 to <3 WU and pulmonary arterial wedge pressure (P...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10037455 Pulmonary vascular disorders NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001353-16 Sponsor Protocol Number: BAY63-2521/16277 Start Date*: 2015-04-17
    Sponsor Name:Bayer AG
    Full Title: A Randomised, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
    Medical condition: diffuse cutaneous systemic sclerosis (dcSSc)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10012977 Diffuse systemic sclerosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) NL (Completed) BE (Completed) ES (Completed) CZ (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005462-34 Sponsor Protocol Number: 202006RCT Start Date*: 2021-06-23
    Sponsor Name:Thoraxklinik Heidelberg gGmbH
    Full Title: An open-label, prospective, single centre study of the effects of Riociguat on RIght VEntricular size and function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
    Medical condition: Symptomatic pulmonary arterial hypertension with a mean pulmonary artery pressure >20 mmHg and pulmonary vascular resistance ≥2 Wood Units, pulmonary arterial wedge pressure ≤15 mmHg (Group I / Nic...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10037401 Pulmonary hypertensions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-018863-40 Sponsor Protocol Number: BAY63-2521/15096 Start Date*: 2010-07-16
    Sponsor Name:Bayer HealthCare AG
    Full Title: An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretre...
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) CZ (Prematurely Ended) PL (Prematurely Ended) AT (Completed) IT (Prematurely Ended) GB (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-001591-30 Sponsor Protocol Number: S-20150201 Start Date*: 2017-11-06
    Sponsor Name:Odense University Hospital
    Full Title: Treatment of congenital nephrogenic diabetes insipidus with a guanylate cyclase stimulator, riociguat or a phosphodiesterase type 5 inhibitor, sildenafil
    Medical condition: Nephrogenic diabetes insipidus because of AVP2R-mutation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10012626 Diabetes nephrogenic (excludes glycosuria) LLT
    Population Age: Adults Gender: Male
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-001008-23 Sponsor Protocol Number: RIOP-1 Start Date*: 2014-09-26
    Sponsor Name:The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
    Full Title: Riociguat in patients with respiratory disease and hypoxia – a proof-of-concept study
    Medical condition: Pulmonary hypertension WHO Group III (Pulmonary hypertension owing to lung disease and/or hypoxia): Chronic obstructive pulmonary disease(COPD); Pulmonary Fibrosis (PF).
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-003539-19 Sponsor Protocol Number: BAY63-2521/11349 Start Date*: 2008-11-26
    Sponsor Name:Bayer HealthCare AG,
    Full Title: Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmo...
    Medical condition: Chronic Thromboembolic Pulmonary Hypertension
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004855 10037406 Pulmonary hypertension secondary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) FR (Completed) AT (Completed) IT (Completed) IE (Prematurely Ended) ES (Completed) BE (Completed) CZ (Completed) PT (Completed) DK (Completed) SK (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-015878-35 Sponsor Protocol Number: BAY63-2521/14308 Start Date*: 2010-03-22
    Sponsor Name:Bayer Healthcare AG
    Full Title: Randomized, double blind, placebo controlled, parallel group, multi-center study to evaluate the hemodynamic effects of Riociguat (BAY 63-2521) as well as safety and kinetics in patients with pulmo...
    Medical condition: Pacientes sintomáticos con una hipertensión pulmonar asociada a una disfunción del ventrículo izquierdo (PH-sLVD)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10037406 Pulmonary hypertension secondary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Trial now transitioned) NL (Completed) BE (Completed) AT (Completed) FR (Completed) GB (Completed) IT (Trial now transitioned) DK (Completed) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-003610-94 Sponsor Protocol Number: BAY63-2521/12935 Start Date*: 2008-11-26
    Sponsor Name:Bayer HealthCare AG
    Full Title: Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arteri...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    15.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) SE (Completed) AT (Completed) GB (Completed) IE (Prematurely Ended) BE (Completed) CZ (Completed) DK (Completed) IT (Completed) NL (Prematurely Ended) ES (Prematurely Ended) PT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2008-003482-68 Sponsor Protocol Number: BAY 63-2521/12934 Start Date*: 2008-11-26
    Sponsor Name:Bayer HealthCare AG
    Full Title: Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptom...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    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) IE (Prematurely Ended) AT (Completed) ES (Completed) NL (Completed) FR (Completed) SE (Completed) GB (Completed) CZ (Completed) DK (Completed) BE (Completed) IT (Completed) PT (Completed) GR (Completed)
    Trial results: View results
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