Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-23 @ 1:41 PM
Study NCT ID:
NCT01557660
Status:
WITHDRAWN
Last Update Posted:
2012-03-26
First Post:
2012-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inhaled Treprostinil for PAH: Open-label Extension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2012-03-14', 'studyFirstSubmitQcDate': '2012-03-15', 'lastUpdatePostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term safety of inhaled treprostinil', 'timeFrame': 'up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Six-minute walk distance', 'timeFrame': 'up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'Open-label extension of RIN-PH-302.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Participation and completion of all required visits for study RIN-PH-302.'}, 'identificationModule': {'nctId': 'NCT01557660', 'acronym': 'INTREPID - OL', 'briefTitle': 'Inhaled Treprostinil for PAH: Open-label Extension', 'organization': {'class': 'INDUSTRY', 'fullName': 'United Therapeutics'}, 'officialTitle': 'Inhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center Study', 'orgStudyIdInfo': {'id': 'RIN-PH-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'inhaled treprostinil', 'interventionNames': ['Drug: inhaled treprostinil']}], 'interventions': [{'name': 'inhaled treprostinil', 'type': 'DRUG', 'description': '0.6mg/mL inhalation solution, up to 12 breaths four times a day', 'armGroupLabels': ['inhaled treprostinil']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}