Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 4:20 PM
Study NCT ID:
NCT01971450
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2013-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 89}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2013-09-20', 'studyFirstSubmitQcDate': '2013-10-24', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days without any drug administration at all', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of fully inhaled doses in relation to the total number of inhalations per day', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of missed doses per day as recommended', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': '6 minute walking distance test (MWDT) value', 'timeFrame': 'Up to 12 months'}, {'measure': 'Score on dyspnea Borg CR (category ratio) 10 scale', 'timeFrame': 'Up to 12 months'}, {'measure': "Patients' quality of life, assessed by validated questionnaire", 'timeFrame': 'Up to 12 months'}, {'measure': 'Assessment of the structural changes in the lungs using X-ray examination of the lungs', 'timeFrame': 'Up to 12 months'}, {'measure': 'Assessment of the structural changes in the lungs using spirography', 'timeFrame': 'Up to 12 months'}, {'measure': 'Assessment of lung haemodynamics using the data of echocardiography', 'timeFrame': 'Up to 12 months'}, {'measure': 'Assessment of lung haemodynamics using the data of catheterization', 'timeFrame': 'Up to 12 months'}, {'measure': 'Reason for omission of inhalation as assessed by the physician', 'timeFrame': 'Up to 12 months'}, {'measure': 'Concomitant medication for other indications than pulmonary hypertension', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Severity of AEs', 'timeFrame': 'Up to 12 months'}, {'measure': 'AE relation to treatment', 'timeFrame': 'Up to 12 months'}, {'measure': 'AE treatment', 'timeFrame': 'Up to 12 months'}, {'measure': 'AE outcomes', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-interventional', 'Ventavis', 'Iloprost', 'Pulmonary hypertension', 'Compliance', 'Russian Federation'], 'conditions': ['Hypertension, Pulmonary']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products.'}]}, 'descriptionModule': {'briefSummary': "Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients ≥ 18 years old with PH, treated with Ventavis and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients ≥ 18 years old\n* Diagnosis of PH\n* Planned or current treatment with Ventavis (not more than 6 month)\n\nExclusion Criteria:\n\n* Contraindications for the use of Ventavis in accordance with the local product information'}, 'identificationModule': {'nctId': 'NCT01971450', 'acronym': 'IVENT', 'briefTitle': 'Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension', 'orgStudyIdInfo': {'id': '16777'}, 'secondaryIdInfos': [{'id': 'VE1311RU', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Iloprost', 'description': 'The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion.', 'interventionNames': ['Drug: Iloprost (Ventavis, BAYQ6256)']}], 'interventions': [{'name': 'Iloprost (Ventavis, BAYQ6256)', 'type': 'DRUG', 'armGroupLabels': ['Iloprost']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Russia'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}