Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:53 AM
Study NCT ID:
NCT00373360
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2006-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C427248', 'term': 'treprostinil'}, {'id': 'D011464', 'term': 'Epoprostenol'}], 'ancestors': [{'id': 'D044062', 'term': 'Prostaglandins I'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rmauthe@unither.com', 'phone': '919-485-8350', 'title': 'Rex Mauthe; Senior Director, Regulatory Affairs', 'organization': 'United Therapeutics Corporation'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restless Leg Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'catheter site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '34.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a small open label study, the statistics applied to the results were descriptive. For all efficacy endpoints, data obtained from study assessments during the treatment phase were compared to Baseline.\n\nassessments'}, {'type': 'SECONDARY', 'title': 'Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.56', 'spread': '0.98', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.\n\nClass II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.\n\nClass III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.\n\nClass IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Dyspnea From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.531', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Edema From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Orthopnea From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.500', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Dizziness From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Fatigue From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change from Baseline to Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Syncope From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Chest Pain From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Effectiveness Score at Baseline', 'categories': [{'measurements': [{'value': '71.6', 'spread': '29.2', 'groupId': 'OG000'}]}]}, {'title': 'Effectiveness Score at Week 8', 'categories': [{'measurements': [{'value': '82.7', 'spread': '23.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Side Effects Score at Baseline', 'categories': [{'measurements': [{'value': '71.5', 'spread': '14.4', 'groupId': 'OG000'}]}]}, {'title': 'Side Effects Score at Week 8', 'categories': [{'measurements': [{'value': '84.7', 'spread': '12.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Convenience Score at Baseline', 'categories': [{'measurements': [{'value': '59.9', 'spread': '14.4', 'groupId': 'OG000'}]}]}, {'title': 'Convenience Score at Week 8', 'categories': [{'measurements': [{'value': '90.7', 'spread': '10.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Global Satisfaction Score at Baseline', 'categories': [{'measurements': [{'value': '84.1', 'spread': '15.1', 'groupId': 'OG000'}]}]}, {'title': 'Global Satisfaction Score at Week 8', 'categories': [{'measurements': [{'value': '92.1', 'spread': '14.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.063', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'CAMPHOR score at Baseline', 'categories': [{'measurements': [{'value': '18.9', 'spread': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'CAMPHOR score at Week 8', 'categories': [{'measurements': [{'value': '12.9', 'spread': '10.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.203', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change Between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a health related quality of life instrument specific to PAH. The total score can range from 0 -75; the higher the score, the worse the outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Much better', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat better', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'About the same', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'Subjects were asked to compare their symptoms of PAH as compared to 8 weeks prior and rate as much better, somewhat better, about the same, somewhat worse, or much worse.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Much less', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat Less', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'About the same', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat more', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Much more', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'Subjects were asked to compare their previous experience with Flolan and rate how much time was spent dealing with intravenous Remodulin therapy as much less, somewhat less, about the same, somewhat more, or much more.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Much more satisfied', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'More satisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'About the same', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Less satisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Much less satisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8', 'description': 'Subjects were asked to compare their previous experience with Flolan and rate satisfaction with intravenous Remodulin therapy over the past two weeks as much more satisfied, more satisfied, about the same, less satisfied, or much less satisfied.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Time to gather/set up epoprostenol at Baseline', 'categories': [{'measurements': [{'value': '34.9', 'spread': '28.7', 'groupId': 'OG000'}]}]}, {'title': 'Time to gather/set up Remodulin at Week 8', 'categories': [{'measurements': [{'value': '27.0', 'spread': '28.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.250', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change from Baseline to Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Time spent to connect epoprostenol at Baseline', 'categories': [{'measurements': [{'value': '23.2', 'spread': '14.4', 'groupId': 'OG000'}]}]}, {'title': 'Time spent to connect Remodulin at Week 8', 'categories': [{'measurements': [{'value': '18.7', 'spread': '13.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.207', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Time to change dressing with epoprostenol at BL', 'categories': [{'measurements': [{'value': '31.4', 'spread': '14.2', 'groupId': 'OG000'}]}]}, {'title': 'Time to change dressing with Remdoluin at Wk 8', 'categories': [{'measurements': [{'value': '28.6', 'spread': '25.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.297', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Time to prepare epoprostenol at Baseline', 'categories': [{'measurements': [{'value': '109.0', 'spread': '61.0', 'groupId': 'OG000'}]}]}, {'title': 'Time to prepare Remodulin at Week 8', 'categories': [{'measurements': [{'value': '47.8', 'spread': '31.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Change between Baseline and Week 8', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Disconnect pump at Baseline (epoprostenol)', 'categories': [{'measurements': [{'value': '7.7', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Disconnect pump at Wk 8 (Remodulin)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'unitOfMeasure': 'number of times per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Check pump at Baseline (epoprostenol)', 'categories': [{'measurements': [{'value': '19.2', 'spread': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'Check pump at Week 8 (Remodulin)', 'categories': [{'measurements': [{'value': '12.2', 'spread': '8.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'unitOfMeasure': 'number of times per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'classes': [{'title': 'Daily alarms at Baseline (epoprostenol)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Daily alarms at Week 8 (Remodulin)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'unitOfMeasure': 'number of times per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subject participated in this study between July 2007 and January 2008.', 'preAssignmentDetails': 'All subjects were required to be receiving continuous intravenous epoprostenol therapy for at least three months and at a stable dose for at least thirty days prior to enrollment in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treprostinil Sodium', 'description': 'All subjects received active treatment with treprostinil sodium.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PAH Etiology', 'classes': [{'title': 'Idiopathic PAH', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Connective Tissue Disease (CTD)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'World Health Organization (WHO) Functional Classification for PAH', 'classes': [{'title': 'Class II', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.', 'unitOfMeasure': 'participants'}, {'title': 'Six minute walk distance', 'classes': [{'categories': [{'measurements': [{'value': '447.7', 'groupId': 'BG000', 'lowerLimit': '195', 'upperLimit': '663'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters', 'dispersionType': 'FULL_RANGE'}, {'title': 'Epoprostenol dose', 'classes': [{'categories': [{'measurements': [{'value': '27.15', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '58'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/kg/min', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-03', 'studyFirstSubmitDate': '2006-09-07', 'resultsFirstSubmitDate': '2012-10-19', 'studyFirstSubmitQcDate': '2006-09-07', 'lastUpdatePostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-03', 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.', 'timeFrame': 'Baseline and Week 8'}], 'secondaryOutcomes': [{'measure': 'Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).'}, {'measure': 'Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.\n\nClass II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.\n\nClass III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.\n\nClass IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity.'}, {'measure': 'Change in Symptoms of Dyspnea From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.'}, {'measure': 'Change in Symptoms of Edema From Baseline to Week 8', 'timeFrame': 'Baseline to Week 8', 'description': 'The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.'}, {'measure': 'Change in Symptoms of Orthopnea From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.'}, {'measure': 'Change in Symptoms of Dizziness From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.'}, {'measure': 'Change in Symptoms of Fatigue From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.'}, {'measure': 'Change in Symptoms of Syncope From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.'}, {'measure': 'Change in Symptoms of Chest Pain From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.'}, {'measure': 'Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.'}, {'measure': 'Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.'}, {'measure': 'Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.'}, {'measure': 'Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.'}, {'measure': 'Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a health related quality of life instrument specific to PAH. The total score can range from 0 -75; the higher the score, the worse the outcome.'}, {'measure': 'Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'Subjects were asked to compare their symptoms of PAH as compared to 8 weeks prior and rate as much better, somewhat better, about the same, somewhat worse, or much worse.'}, {'measure': 'Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'Subjects were asked to compare their previous experience with Flolan and rate how much time was spent dealing with intravenous Remodulin therapy as much less, somewhat less, about the same, somewhat more, or much more.'}, {'measure': 'Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'Subjects were asked to compare their previous experience with Flolan and rate satisfaction with intravenous Remodulin therapy over the past two weeks as much more satisfied, more satisfied, about the same, less satisfied, or much less satisfied.'}, {'measure': 'Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'timeFrame': 'Baseline and Week 8'}, {'measure': 'Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'timeFrame': 'Baseline and Week 8'}, {'measure': 'Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'timeFrame': 'Baseline and Week 8'}, {'measure': 'Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'timeFrame': 'Baseline and Week 8'}, {'measure': 'Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'timeFrame': 'Baseline and Week 8'}, {'measure': 'Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'timeFrame': 'Baseline and Week 8'}, {'measure': 'Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol', 'timeFrame': 'Baseline and Week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pulmonary hypertension', 'PAH', 'Remodulin', 'treprostinil', 'Quality of Life', 'Rapid Switch'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.', 'detailedDescription': 'Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to ameliorate symptoms of PAH and to improve health related quality of life (HRQOL).\n\nRemodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the IV and SC routes of administration. Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs. Furthermore, since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog. In an open-label study in Europe, patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects. This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension using the CADD legacy pump.\n\nParticipation in this study will last approximately 10 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participants will have 4 visits during the study and will spend at least 1 night in the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 70 years\n* Diagnosis of Idiopathic or Familial Pulmonary Arterial Hypertension (PAH)or PAH associated with a collagen vascular disease or PAH associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH associated with portal hypertension with mild or moderate hepatic dysfunction (Grade of A or B on the Child-Pugh Classification Scale)or PAH associated with drug or toxins or CTEPH\n* WHO Class II-III\n* Currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.\n* Have central intravenous catheter\n* Optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month.\n* Mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.\n\nExclusion Criteria:\n\n* Nursing or pregnant woman\n* Have any other type of PAH due to conditions other than noted in the above inclusion criteria, including but not limited to PAH related to thrombotic or embolic disease\n* Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis)\n* Changes to chronic PAH therapy (i.e., new therapy added within last 30 days\\[including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil\\] or PAH medication discontinued within 7 days of study entry.\n* Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.\n* Central venous line infection within the past 30 days.\n* Previous documented evidence of significant parenchymal lung disease\n* Evidence or history of left-sided heart disease\n* Musculoskeletal disorder or any other disease, which is thought to limit ambulation, or be connected to a machine that is not portable\n* Uncontrolled hypertension, chronic renal insufficiency, or active infection.\n* Use of investigational drug within past 30 days.'}, 'identificationModule': {'nctId': 'NCT00373360', 'briefTitle': 'Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin', 'organization': {'class': 'INDUSTRY', 'fullName': 'United Therapeutics'}, 'officialTitle': 'Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction', 'orgStudyIdInfo': {'id': 'RIV-PH-411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: treprostinil sodium']}], 'interventions': [{'name': 'treprostinil sodium', 'type': 'DRUG', 'otherNames': ['Remodulin', 'Flolan'], 'description': 'rapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Omar Minai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}