Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-25 @ 6:42 PM
Study NCT ID:
NCT02825160
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], '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': 'D016285', 'term': 'Iloprost'}], 'ancestors': [{'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-07-04', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment emergent adverse events (TEAE) of special interest.', 'timeFrame': 'Up to 5 years', 'description': 'TEAE of special interest:\n\n* Hypotension\n* Syncope\n* Local irritation\n* Bleeding events\n* Thrombocytopenia\n* Tachycardia'}, {'measure': 'Number of participants with adverse drug reaction', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months', 'timeFrame': 'Baseline and 3 months,Baseline and 12 months,'}, {'measure': 'Change from baseline in 6-Minute Walking Distance after 3 and 12 months', 'timeFrame': 'Baseline and 3 months,Baseline and 12 months'}, {'measure': 'Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months', 'timeFrame': 'Baseline and 3 months,Baseline and 12 months'}, {'measure': 'Change in blood concentration from baseline in brain natriuretic peptide / N-terminal pro-brain natriuretic peptide (BPN/NT-pro BNP) after 3 and 12 months.', 'timeFrame': 'Baseline and 3 months,Baseline and 12 months'}, {'measure': 'Change from baseline in WHO functional class after 3 and 12 months', 'timeFrame': 'Baseline and 3 months,Baseline and 12 months,'}, {'measure': 'Time to Clinical Worsening', 'timeFrame': 'Up to 5 years', 'description': 'The 1st occurrence date of one of the following events is recorded and used for the calculation of time to clinical worsening:\n\n* Death (all-cause mortality), -Heart/lung transplantation, -Atrial Septostomy,\n* Hospitalization due to persistent worsening of Pulmonary Hypertension (PH),\n* Start of new PH specific treatment or modification of a preexisting Prostacycline analogues treatment except Ventavis due to worsening PH,\n* Persistent decrease in 6MWD due to worsening PH,\n* Persistent worsening of WHO functional class due to deterioration of PH'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iloprost', 'Ventavis', 'Prostacycline analogue', 'Pulmonary arterial hypertension', 'Japan', 'Post-marketing surveillance'], 'conditions': ['Hypertension, Pulmonary']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': "Click here for access to information about Bayer's transparency standards and Bayer studies."}]}, 'descriptionModule': {'briefSummary': 'This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH', 'detailedDescription': 'This local, prospective, non-interventional, company sponsored, multi-center, single-cohort study includes patients treated with Ventavis for PAH. A total of 270 patients (valid for safety analysis) is planned to be enrolled in 5 years. Target population is patients with PAH diagnosis. This study is performed as an all-patient investigation, therefore all patients who receive Ventavis treatment for PAH need to be registered. The treatment should be performed based on the product label in Japan. The standard observation period will last for 12 months from starting Ventavis treatment. In addition, the extension observation will be carried out as long as Ventavis treatment continues or at most for more 4 years. The standard observation points are 3 month and\n\n1 to 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population includes PAH patients treated with Ventavis. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Ventavis for PAH need to be registered in principle, until the target number of patients reached.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients diagnosed with PAH\n* Patients for whom the decision to initiate treatment with Ventavis was made as per investigator's routine treatment practice.\n\nExclusion Criteria:\n\n\\- N/A"}, 'identificationModule': {'nctId': 'NCT02825160', 'briefTitle': 'Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)', 'orgStudyIdInfo': {'id': '17941'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ventavis', 'description': 'Ventavis treatment group', 'interventionNames': ['Drug: Ventavis (Iloprost, BAYQ6256)']}], 'interventions': [{'name': 'Ventavis (Iloprost, BAYQ6256)', 'type': 'DRUG', 'description': 'The treatment of Ventavis should comply with the local product information', 'armGroupLabels': ['Ventavis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Many Locations'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}