Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-03 @ 5:39 PM
Study NCT ID:
NCT02092818
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2014-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'China', 'Israel', 'Kazakhstan', 'Mexico', 'Oman', 'Singapore', 'Slovenia', 'South Korea', 'Ukraine', 'United Arab Emirates', 'Venezuela']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542595', 'term': 'riociguat'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1316}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-18', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of serious adverse events', 'timeFrame': 'Up to 4 years'}, {'measure': 'All-cause mortality', 'timeFrame': 'Up to 4 years'}], 'secondaryOutcomes': [{'measure': 'Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of AE of special interest overall', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of AE of special interest in different PH indications (PAH, CTEPH)', 'timeFrame': 'Up to 4 years'}, {'measure': '6 minute walking distance', 'timeFrame': 'Up to 4 years'}, {'measure': 'Functional class of pulmonary hypertension according to NYHA/ WHO', 'timeFrame': 'Up to 4 years', 'description': 'NYHA/ WHO: New York Heart Association / World Health Organization'}, {'measure': 'Borg Dyspnoea Index', 'timeFrame': 'Up to 4 years'}, {'measure': 'EQ5D visual analogue scale (VAS) score', 'timeFrame': 'Up to 4 years', 'description': 'EQ5D: EurQuol 5 dimensions (questionnaire)'}, {'measure': 'Number of patients with hemodynamic measurements', 'timeFrame': 'Up to 4 years'}, {'measure': 'Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP))', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of hospitalization', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of outpatient visits', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of days in home care', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of days in rehabilitation', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of days in nursery home', 'timeFrame': 'Up to 4 years'}, {'measure': 'Drug treatment for PH', 'timeFrame': 'Up to 4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension, Pulmonary']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products.'}]}, 'descriptionModule': {'briefSummary': 'In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been prescribed Adempas® for a medically appropriate use', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male patients who start or are on treatment with Adempas\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients currently participating in an interventional clinical trial'}, 'identificationModule': {'nctId': 'NCT02092818', 'acronym': 'EXPERT', 'briefTitle': 'EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension', 'orgStudyIdInfo': {'id': '16657'}, 'secondaryIdInfos': [{'id': 'AD1301', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients who have been prescribed Adempas for a medically appropriate use', 'interventionNames': ['Drug: Riociguat (Adempas, BAY63-2521)']}], 'interventions': [{'name': 'Riociguat (Adempas, BAY63-2521)', 'type': 'DRUG', 'description': 'The decision on clinical management of the patient including the actual treatment duration will be determined solely by the physician not by the clinical study protocol (CSP)', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Argentina'}, {'city': 'Multiple Locations', 'country': 'Australia'}, {'city': 'Multiple Locations', 'country': 'Austria'}, {'city': 'Multiple Locations', 'country': 'Belgium'}, {'city': 'Multiple Locations', 'country': 'Canada'}, {'city': 'Multiple Locations', 'country': 'Colombia'}, {'city': 'Multiple Locations', 'country': 'Czechia'}, {'city': 'Multiple Locations', 'country': 'Denmark'}, {'city': 'Multiple Locations', 'country': 'Estonia'}, {'city': 'Multiple Locations', 'country': 'Finland'}, {'city': 'Multiple Locations', 'country': 'France'}, {'city': 'Multiple Locations', 'country': 'Germany'}, {'city': 'Multiple Locations', 'country': 'Greece'}, {'city': 'Multiple Locations', 'country': 'Ireland'}, {'city': 'Multiple Locations', 'country': 'Italy'}, {'city': 'Multiple Locations', 'country': 'Luxembourg'}, {'city': 'Multiple Locations', 'country': 'Netherlands'}, {'city': 'Multiple Locations', 'country': 'Norway'}, {'city': 'Multiple Locations', 'country': 'Portugal'}, {'city': 'Multiple Locations', 'country': 'Russia'}, {'city': 'Multiple Locations', 'country': 'Saudi Arabia'}, {'city': 'Multiple Locations', 'country': 'Slovakia'}, {'city': 'Multiple Locations', 'country': 'Spain'}, {'city': 'Multiple Locations', 'country': 'Sweden'}, {'city': 'Multiple Locations', 'country': 'Switzerland'}, {'city': 'Multiple Locations', 'country': 'Taiwan'}, {'city': 'Multiple Locations', 'country': 'Turkey (Türkiye)'}, {'city': 'Multiple Locations', 'country': 'United Kingdom'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}