Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-08 @ 8:45 PM
Study NCT ID:
NCT01406327
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2011-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'C467894', 'term': 'ambrisentan'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan', 'timeFrame': '1 year'}, {'measure': 'The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage', 'timeFrame': '1 year'}, {'measure': 'The number of adverse events and clinical course in subjects with hepatic dysfunction', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension, Pulmonary']}, 'referencesModule': {'references': [{'pmid': '29282676', 'type': 'DERIVED', 'citation': 'Takahashi T, Hayata S, Kobayashi A, Onaka Y, Ebihara T, Hara T. Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report). Clin Drug Investig. 2018 Mar;38(3):219-229. doi: 10.1007/s40261-017-0602-4.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items;\n\n1. Unknown adverse drug reactions (ADRs)\n2. Incidence of ADRs to medical products in actual clinical practice\n3. Factors influencing safety of ambrisentan\n4. Factors influencing efficacy of ambrisentan\n5. Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All Japanese subjects who have received ambrisentan for the first time for the treatment of pulmonary arterial hypertension (PAH) and have given their consent to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must use ambrisentan for the first time\n\nExclusion Criteria:\n\n* Subjects with hypersensitivity to ambrisentan\n* Subjects who is pregnant or might be pregnant\n* Subjects with severe hepatic disorder'}, 'identificationModule': {'nctId': 'NCT01406327', 'briefTitle': 'Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)', 'orgStudyIdInfo': {'id': '114782'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects prescribed ambrisentan', 'description': 'Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period', 'interventionNames': ['Drug: Ambrisentan']}], 'interventions': [{'name': 'Ambrisentan', 'type': 'DRUG', 'description': 'Ambrisentan', 'armGroupLabels': ['Subjects prescribed ambrisentan']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}