Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-28 @ 6:52 PM
Study NCT ID:
NCT02576002
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2691}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2015-10-13', 'studyFirstSubmitQcDate': '2015-10-14', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of PAH (pulmonary arterial hypertension)', 'timeFrame': 'Retrospective analysis of three year period'}, {'measure': 'Prevalence rate of PAH', 'timeFrame': 'Retrospective analysis of three year period'}], 'secondaryOutcomes': [{'measure': 'Assigned drug treatment for PAH measured using the MarketScan database', 'timeFrame': 'Retrospective analysis of three year period', 'description': 'Description of pulmonary hypertension-targeted drugs prescribed in the study population and changes during the study period'}, {'measure': 'Diagnostic procedures performed among PAH patients measured using the MarketScan database', 'timeFrame': 'Retrospective analysis of three year period'}, {'measure': 'Prevalence of comorbidities among PAH patients', 'timeFrame': 'Retrospective analysis of three year period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Arterial Hypertension'], 'conditions': ['Hypertension, Pulmonary']}, 'descriptionModule': {'briefSummary': 'To describe the prevalence, incidence and current treatment and procedures patterns in a US pediatric population with PAH in MarketScan database during the period 2010-2013'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be all patients who were born after 1991 and thus under the age of 18 during the years 2010 to 2013 in the MarketScan data. The larger population of patients under age 18 will comprise the general population from which population-based prevalence rates will be derived.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All PAH patients who were in the MarketScan database and who were under age 18 at some time during the years 2010 through 2013\n\nExclusion Criteria:\n\nNot applicable'}, 'identificationModule': {'nctId': 'NCT02576002', 'briefTitle': 'Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Study to Estimate the Incidence and Prevalence and Treatment Patterns of Pediatric Pulmonary Hypertension in the US', 'orgStudyIdInfo': {'id': '18515'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric PAH patients', 'description': 'US pediatric population with PAH in MarketScan database during the period 2010-2013', 'interventionNames': ['Drug: Assigned pulmonary hypertension medication']}], 'interventions': [{'name': 'Assigned pulmonary hypertension medication', 'type': 'DRUG', 'description': 'As assigned by treating physician; may include following product classes: - Calcium channel blockers/antagonists - Prostanoids (prostaglandins, thromboxanes, prostacyclines) - Endothelin receptor antagonists - PDE-5 inhibitors - SGc stimulators', 'armGroupLabels': ['Pediatric PAH patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}