Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-30 @ 5:09 AM
Study NCT ID:
NCT00517933
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2007-08-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kevin.anstrom@duke.edu', 'phone': '919-668-8902', 'title': 'Kevin J Anstrom, PhD', 'organization': 'Duke Clinical Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Findings are limited to patients with advanced IPF. It is unknown if treatment effect was driven by particular subgroup of patients. Study was too short and enrolled too few to assess duration of effect.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks', 'otherNumAtRisk': 89, 'otherNumAffected': 72, 'seriousNumAtRisk': 89, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks', 'otherNumAtRisk': 91, 'otherNumAffected': 62, 'seriousNumAtRisk': 91, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Respiratory, thoracic, or mediastinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection or infestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis ischemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peptic ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at Week 12', 'description': 'This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '6-minute Walk Distance (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': '1st baseline', 'categories': [{'measurements': [{'value': '246.93', 'spread': '99.11', 'groupId': 'OG000'}, {'value': '267.71', 'spread': '127.75', 'groupId': 'OG001'}]}]}, {'title': '2nd baseline', 'categories': [{'measurements': [{'value': '246.39', 'spread': '103.40', 'groupId': 'OG000'}, {'value': '269.55', 'spread': '129.83', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '237.29', 'spread': '121.48', 'groupId': 'OG000'}, {'value': '257.55', 'spread': '139.44', 'groupId': 'OG001'}]}]}, {'title': '12 week', 'categories': [{'measurements': [{'value': '239.09', 'spread': '126.39', 'groupId': 'OG000'}, {'value': '249.48', 'spread': '138.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 week, 12 week', 'description': 'The 6MWT measures the distance that a participant can walk in a period of 6 minutes.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.5', 'groupId': 'OG000', 'lowerLimit': '-43.2', 'upperLimit': '-13.8'}, {'value': '-45.2', 'groupId': 'OG001', 'lowerLimit': '-59.7', 'upperLimit': '-30.8'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.7', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '37.3', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12', 'description': 'The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'meters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Desaturation During 6-minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil / Sildenafil', 'description': '20 mg oral sildenafil 3 times per day'}, {'id': 'OG001', 'title': 'Placebo / Sildenafil', 'description': '20 mg oral placebo 3 times per day'}], 'classes': [{'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '91.0'}, {'value': '75.3', 'groupId': 'OG001', 'lowerLimit': '65.3', 'upperLimit': '84.3'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Change in Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '-3.10', 'upperLimit': '3.54'}, {'value': '6.81', 'groupId': 'OG001', 'lowerLimit': '3.53', 'upperLimit': '10.08'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.58', 'ciLowerLimit': '-11.25', 'ciUpperLimit': '-1.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured from enrollment to 12 weeks (phase I)', 'description': 'The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '50.71', 'spread': '22.00', 'groupId': 'OG000'}, {'value': '43.28', 'spread': '20.18', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '49.67', 'spread': '22.74', 'groupId': 'OG000'}, {'value': '47.64', 'spread': '25.61', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'categories': [{'measurements': [{'value': '50.58', 'spread': '23.41', 'groupId': 'OG000'}, {'value': '48.13', 'spread': '24.10', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 6 weeks', 'categories': [{'measurements': [{'value': '-1.27', 'spread': '12.63', 'groupId': 'OG000'}, {'value': '4.42', 'spread': '17.16', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 12 weeks', 'categories': [{'measurements': [{'value': '0.30', 'spread': '16.01', 'groupId': 'OG000'}, {'value': '6.99', 'spread': '18.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores)\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Forced Vital Capacity (FVC) Adjusted Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil / Sildenafil', 'description': '20 mg oral sildenafil 3 times per day'}, {'id': 'OG001', 'title': 'Placebo / Sildenafil', 'description': '20 mg oral placebo 3 times per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '-0.00'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '-0.01'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.07', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil / Sildenafil', 'description': '20 mg oral sildenafil 3 times per day'}, {'id': 'OG001', 'title': 'Placebo / Sildenafil', 'description': '20 mg oral placebo 3 times per day'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.25', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '2.25', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '2.40', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.22', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 6 weeks', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, Week 12', 'description': 'Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil / Sildenafil', 'description': '20 mg oral sildenafil 3 times per day'}, {'id': 'OG001', 'title': 'Placebo / Sildenafil', 'description': '20 mg oral placebo 3 times per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '0.7'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '-0.8'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '0.1', 'ciUpperLimit': '3.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'percentage of predicted (DLCO)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil / Sildenafil', 'description': '20 mg oral sildenafil 3 times per day'}, {'id': 'OG001', 'title': 'Placebo / Sildenafil', 'description': '20 mg oral placebo 3 times per day'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.81', 'spread': '6.03', 'groupId': 'OG000'}, {'value': '26.73', 'spread': '6.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '26.00', 'spread': '7.05', 'groupId': 'OG000'}, {'value': '26.11', 'spread': '6.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '25.66', 'spread': '6.79', 'groupId': 'OG000'}, {'value': '25.38', 'spread': '7.43', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 6 weeks', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '4.35', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '4.59', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '4.58', 'groupId': 'OG000'}, {'value': '-1.78', 'spread': '6.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, Week 12', 'description': 'Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups', 'unitOfMeasure': 'percentage of predicted (DLCO)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-0.30', 'upperLimit': '0.37'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.70'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '0.14', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 week', 'description': 'The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.72', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '3.53', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '1.79', 'groupId': 'OG001'}]}]}, {'title': '12 week', 'categories': [{'measurements': [{'value': '3.76', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '3.49', 'spread': '1.61', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 6 week', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 12 week', 'categories': [{'measurements': [{'value': '0.09', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '1.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 week, 12 week', 'description': 'The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in St. George's Respiratory Questionnaire (Total Score) (Adjusted Values)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '0.6'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '4.7'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '-0.9', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 week', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "St. George's Respiratory Questionnaire (Total Score)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '54.55', 'spread': '16.46', 'groupId': 'OG000'}, {'value': '51.72', 'spread': '15.86', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '52.56', 'spread': '16.81', 'groupId': 'OG000'}, {'value': '51.74', 'spread': '16.45', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'categories': [{'measurements': [{'value': '52.58', 'spread': '16.35', 'groupId': 'OG000'}, {'value': '52.19', 'spread': '16.26', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 6 weeks', 'categories': [{'measurements': [{'value': '-1.45', 'spread': '10.11', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '10.53', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-1.71', 'spread': '12.35', 'groupId': 'OG000'}, {'value': '2.88', 'spread': '10.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': "Mean raw scores of the St. George's Respiratory Questionnaire. The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in St. George's Respiratory Questionnaire (Symptoms Score) Adjusted Value", 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.6', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '-0.1'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '5.6'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.7', 'ciLowerLimit': '-10.6', 'ciUpperLimit': '-0.9', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "St. George's Respiratory Questionnaire (Symptoms Score)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '58.20', 'spread': '17.75', 'groupId': 'OG000'}, {'value': '53.99', 'spread': '18.90', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '55.89', 'spread': '17.72', 'groupId': 'OG000'}, {'value': '56.26', 'spread': '18.77', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'categories': [{'measurements': [{'value': '54.49', 'spread': '17.59', 'groupId': 'OG000'}, {'value': '55.55', 'spread': '19.08', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 6 weeks', 'categories': [{'measurements': [{'value': '-2.05', 'spread': '16.72', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '16.30', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-3.57', 'spread': '17.95', 'groupId': 'OG000'}, {'value': '2.80', 'spread': '14.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George's Respiratory Questionnaire.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in St. George's Respiratory Questionnaire (Activity Score) Adjusted Value", 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '1.4'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.0'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "St. George's Respiratory Questionnaire (Activity Score)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '71.20', 'spread': '17.50', 'groupId': 'OG000'}, {'value': '68.02', 'spread': '17.63', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '69.95', 'spread': '18.66', 'groupId': 'OG000'}, {'value': '67.44', 'spread': '18.51', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'categories': [{'measurements': [{'value': '69.75', 'spread': '18.63', 'groupId': 'OG000'}, {'value': '69.13', 'spread': '19.34', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 6 weeks', 'categories': [{'measurements': [{'value': '-1.95', 'spread': '10.82', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '10.87', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-1.25', 'spread': '12.56', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '13.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in St. George's Respiratory Questionnaire (Impacts Score) Adjusted Value", 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '2.0'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '-0.0', 'upperLimit': '5.7'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.7', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '0.4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "St. George's Respiratory Questionnaire (Impacts Score)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '43.20', 'spread': '19.26', 'groupId': 'OG000'}, {'value': '39.77', 'spread': '18.81', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '41.62', 'spread': '19.49', 'groupId': 'OG000'}, {'value': '41.58', 'spread': '19.68', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'categories': [{'measurements': [{'value': '41.95', 'spread': '19.23', 'groupId': 'OG000'}, {'value': '41.05', 'spread': '18.81', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 6 weeks', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '12.79', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '12.94', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-0.91', 'spread': '15.90', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '13.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in ICECAP-O Adjusted Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '0.03'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.00'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.06', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best).\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICECAP-O', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 6 weeks', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 12 weeks', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Mean raw scores of ICECAP-O.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in EuroQOL Thermometer (Adjusted Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '4.1'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-5.3', 'upperLimit': '1.7'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '7.3', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EuroQOL Thermometer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '66.49', 'spread': '17.45', 'groupId': 'OG000'}, {'value': '67.66', 'spread': '16.98', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '69.47', 'spread': '16.92', 'groupId': 'OG000'}, {'value': '67.09', 'spread': '19.65', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'categories': [{'measurements': [{'value': '66.96', 'spread': '16.45', 'groupId': 'OG000'}, {'value': '67.05', 'spread': '16.37', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 6 weeks', 'categories': [{'measurements': [{'value': '2.51', 'spread': '15.32', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '17.23', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 12 weeks', 'categories': [{'measurements': [{'value': '0.49', 'spread': '17.28', 'groupId': 'OG000'}, {'value': '-2.12', 'spread': '19.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.\n\nMean raw scores of EuroQOL Thermometer.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in EuroQOL (EQ-5D) Utility - Adjusted Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.03'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '0.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EuroQOL (EQ-5D) Utility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 6 weeks', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.\n\nMean raw scores of EuroQOL Utility.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Short Form Health Survey (SF36) General Health - Adjusted Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '0.4'}, {'value': '-3.9', 'groupId': 'OG001', 'lowerLimit': '-5.4', 'upperLimit': '-2.4'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '0.8', 'ciUpperLimit': '5.0', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.\n\nEach score ranges from 0 to 100, with a higher score indicating better function.\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Short Form Health Survey (SF36) General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '36.99', 'spread': '9.64', 'groupId': 'OG000'}, {'value': '37.66', 'spread': '8.73', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '36.00', 'spread': '9.85', 'groupId': 'OG000'}, {'value': '34.97', 'spread': '8.64', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'categories': [{'measurements': [{'value': '36.31', 'spread': '8.91', 'groupId': 'OG000'}, {'value': '34.39', 'spread': '8.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.\n\nEach score ranges from 0 to 100, with a higher score indicating better function.\n\nMean raw scores of SF36 General Health', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in SF36 Aggregate Physical (Adjusted Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '0.8'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '1.7', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.\n\nEach score ranges from 0 to 100, with a higher score indicating better function.\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Short Form Health Survey (SF36) Aggregate Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '-1.68', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '-1.70', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'categories': [{'measurements': [{'value': '-1.71', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to week 6', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to week 12', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.\n\nEach score ranges from 0 to 100, with a higher score indicating better function.\n\nMean raw scores of SF36 Aggregate Physical.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sildenafil / Sildenafil', 'description': '20 mg oral sildenafil 3 times per day'}, {'id': 'FG001', 'title': 'Placebo / Sildenafil', 'description': '20 mg oral placebo 3 times per day'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients decreased due to death, adverse event, lost to follow up and other (see below)', 'groupId': 'FG000', 'numSubjects': '89'}, {'comment': 'Patients decreased due to death, adverse event and other (see below)', 'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Underwent lung transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2 patients terminated after completion of period one, but before starting period 2', 'groupId': 'FG000', 'numSubjects': '79'}, {'comment': '2 patients terminated after completion of period one, but before starting period 2', 'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Underwent lung transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sildenafil', 'description': '20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': '20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '68.2', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '69.0', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2007-08-15', 'resultsFirstSubmitDate': '2010-11-05', 'studyFirstSubmitQcDate': '2007-08-15', 'lastUpdatePostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-23', 'studyFirstPostDateStruct': {'date': '2007-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)', 'timeFrame': 'Measured at Week 12', 'description': 'This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}], 'secondaryOutcomes': [{'measure': '6-minute Walk Distance (6MWT)', 'timeFrame': 'Baseline, 6 week, 12 week', 'description': 'The 6MWT measures the distance that a participant can walk in a period of 6 minutes.'}, {'measure': 'Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance', 'timeFrame': 'Baseline, week 12', 'description': 'The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}, {'measure': 'Desaturation During 6-minute Walk Test (6MWT)', 'timeFrame': 'Week 12', 'description': 'The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis.'}, {'measure': 'Change in Dyspnea', 'timeFrame': 'Measured from enrollment to 12 weeks (phase I)', 'description': 'The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better.'}, {'measure': 'University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores)\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}, {'measure': 'Change in Forced Vital Capacity (FVC) Adjusted Values', 'timeFrame': 'Baseline, Week 12', 'description': 'Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}, {'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': 'Baseline, Week 6, Week 12', 'description': 'Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups'}, {'measure': 'Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values', 'timeFrame': 'Baseline, Week 12', 'description': 'Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}, {'measure': 'Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)', 'timeFrame': 'Baseline, Week 6, Week 12', 'description': 'Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups'}, {'measure': 'Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values)', 'timeFrame': 'Baseline, 12 week', 'description': 'The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}, {'measure': 'Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores)', 'timeFrame': 'Baseline, 6 week, 12 week', 'description': 'The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test.'}, {'measure': "Change in St. George's Respiratory Questionnaire (Total Score) (Adjusted Values)", 'timeFrame': 'Baseline, 12 week', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo."}, {'measure': "St. George's Respiratory Questionnaire (Total Score)", 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': "Mean raw scores of the St. George's Respiratory Questionnaire. The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.)"}, {'measure': "Change in St. George's Respiratory Questionnaire (Symptoms Score) Adjusted Value", 'timeFrame': 'Baseline, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo."}, {'measure': "St. George's Respiratory Questionnaire (Symptoms Score)", 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George's Respiratory Questionnaire."}, {'measure': "Change in St. George's Respiratory Questionnaire (Activity Score) Adjusted Value", 'timeFrame': 'Baseline, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo."}, {'measure': "St. George's Respiratory Questionnaire (Activity Score)", 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire."}, {'measure': "Change in St. George's Respiratory Questionnaire (Impacts Score) Adjusted Value", 'timeFrame': 'Baseline, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo."}, {'measure': "St. George's Respiratory Questionnaire (Impacts Score)", 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': "The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire."}, {'measure': 'Change in ICECAP-O Adjusted Value', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best).\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}, {'measure': 'ICECAP-O', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Mean raw scores of ICECAP-O.'}, {'measure': 'Change in EuroQOL Thermometer (Adjusted Value)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}, {'measure': 'EuroQOL Thermometer', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.\n\nMean raw scores of EuroQOL Thermometer.'}, {'measure': 'Change in EuroQOL (EQ-5D) Utility - Adjusted Value', 'timeFrame': 'Baseline, 12 weeks', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}, {'measure': 'EuroQOL (EQ-5D) Utility', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.\n\nMean raw scores of EuroQOL Utility.'}, {'measure': 'Change in Short Form Health Survey (SF36) General Health - Adjusted Value', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.\n\nEach score ranges from 0 to 100, with a higher score indicating better function.\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}, {'measure': 'Short Form Health Survey (SF36) General Health', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.\n\nEach score ranges from 0 to 100, with a higher score indicating better function.\n\nMean raw scores of SF36 General Health'}, {'measure': 'Change in SF36 Aggregate Physical (Adjusted Value)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.\n\nEach score ranges from 0 to 100, with a higher score indicating better function.\n\nValues adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.'}, {'measure': 'Short Form Health Survey (SF36) Aggregate Physical', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.\n\nEach score ranges from 0 to 100, with a higher score indicating better function.\n\nMean raw scores of SF36 Aggregate Physical.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Idiopathic Pulmonary Fibrosis', 'Pulmonary Hypertension'], 'conditions': ['Pulmonary Fibrosis', 'Hypertension, Pulmonary']}, 'referencesModule': {'references': [{'pmid': '26111071', 'type': 'DERIVED', 'citation': 'Andrade J, Schwarz M, Collard HR, Gentry-Bumpass T, Colby T, Lynch D, Kaner RJ; IPFnet Investigators. The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet): diagnostic and adjudication processes. Chest. 2015 Oct;148(4):1034-1042. doi: 10.1378/chest.14-2889.'}, {'pmid': '25890798', 'type': 'DERIVED', 'citation': 'Durheim MT, Collard HR, Roberts RS, Brown KK, Flaherty KR, King TE Jr, Palmer SM, Raghu G, Snyder LD, Anstrom KJ, Martinez FJ; IPFnet investigators. Association of hospital admission and forced vital capacity endpoints with survival in patients with idiopathic pulmonary fibrosis: analysis of a pooled cohort from three clinical trials. Lancet Respir Med. 2015 May;3(5):388-96. doi: 10.1016/S2213-2600(15)00093-4. Epub 2015 Apr 15.'}, {'pmid': '20484178', 'type': 'DERIVED', 'citation': 'Idiopathic Pulmonary Fibrosis Clinical Research Network; Zisman DA, Schwarz M, Anstrom KJ, Collard HR, Flaherty KR, Hunninghake GW. A controlled trial of sildenafil in advanced idiopathic pulmonary fibrosis. N Engl J Med. 2010 Aug 12;363(7):620-8. doi: 10.1056/NEJMoa1002110. Epub 2010 May 18.'}], 'seeAlsoLinks': [{'url': 'http://www.ipfnet.org', 'label': 'Click here for the Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet) Web site'}]}, 'descriptionModule': {'briefSummary': "Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. This study will evaluate the effectiveness of sildenafil, a medication that increases blood flow to the lungs, at improving breathing function, exercise capacity, and quality of life in people with advanced IPF.", 'detailedDescription': "IPF is a disease in which fibrous tissue clogs the lungs. This eventually damages air sacs in the lungs and leads to widespread and permanent scarring of lung tissue. Individuals with IPF may experience breathing difficulties, cough, chest pain, and a decreased exercise capacity. Pulmonary hypertension, which is high blood pressure in the arteries of the lungs, affects half of all people with IPF. The fibrous tissue that clogs the lungs also blocks blood from flowing through the lungs effectively, reducing the amount of oxygen in the lungs. The fibrous tissue also reduces the lungs' ability to use what oxygen is available. These factors can cause breathing difficulties and may eventually lead to heart disease. Sildenafil is a medication that can increase blood supply to the lungs and reduce the heart's workload. The purpose of this study is to evaluate the effectiveness of sildenafil at improving breathing function, exercise capacity, and quality of life in people with advanced IPF.\n\nThis study will enroll people with advanced IPF. Participants will be randomly assigned to receive sildenafil or placebo three times a day for 12 weeks. Study visits will occur at baseline and Weeks 1, 6, and 12. At Week 12, participants will have the option to continue in the study for an additional 12 weeks. All participants who agree to continue in the study will receive sildenafil three times a day for the second 12 weeks. Study visits will occur at Weeks 13, 18, and 24. At all study visits, a physical exam and blood collection will occur. At selected visits, the following study procedures will occur: lung function testing; urine collection; a 6-minute walk test, which will measure the distance walked in a 6-minute period; and questionnaires to assess health status, breathing, and quality of life. Participants will record medication usage and symptoms in a daily diary. Study researchers will review medical records and the Social Security death index 5 years following the end of the study to determine the incidence of death among study participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of IPF\n* Diffusing capacity of the lung (DLCO) level less than 35% (adjusted for hemoglobin)\n\nExclusion Criteria:\n\n* Current enrollment in another investigational study\n* Six-minute walk distance of less than 50 meters at screening or study entry\n* Difference of greater than 15% between the screening and study entry 6-minute walk distance\n* Acute or long-term impairment other than dyspnea (e.g., angina pectoris, intermittent claudication) that limits the ability to comply with the 6-minute walk test or other study requirements\n* Forced Expiratory Volume 1-second (FEV1)/forced vital capacity (FVC) ratio of less than 0.65 after bronchodilator use\n* Extent of emphysema greater than the extent of fibrotic change (e.g., honeycombing, reticular changes) on high-resolution computed tomography (HRCT) scan\n* Acute heart attack within the 6 months prior to study entry\n* Nitrate use\n* Hypersensitivity to sildenafil or any component of the formulation\n* Presence of aortic stenosis (AS)\n* Life-threatening arrhythmia within 1 month of study entry\n* Diabetes mellitus requiring insulin therapy\n* Second-degree or third-degree atrioventricular (AV) block on electrocardiogram\n* Severe chronic heart failure, defined by left ventricular ejection fraction (LVEF) of less than 25%\n* Presence of idiopathic hypertrophic subaortic stenosis (IHSS)\n* Hypotension (i.e., systolic blood pressure \\[SBP\\] less than 100 mm Hg or diastolic blood pressure \\[DBP\\] less than 50 mm Hg)\n* Uncontrolled systemic hypertension (i.e., SBP greater than 180 mm Hg or DBP greater than 100 mm Hg)\n* Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma, leukemia) that may predispose participant to priapism\n* Aspartate aminotransferase (AST), serum glutamic pyruvic transaminase (SGPT), alanine aminotransferase (ALT), or serum glutamic oxaloacetic transaminase (SGOT) greater than three times the upper limit of normal range\n* Kidney impairment (i.e., creatinine clearance less than 30 mL/minute)\n* Current drug or alcohol dependence\n* Retinitis pigmentosa\n* History of vision loss\n* History of nonarteritic ischemic optic neuropathy\n* Recently initiated pulmonary rehabilitation within 30 days of study entry. Participants will be prohibited from starting pulmonary rehabilitation during the study. Participants who are currently undergoing maintenance pulmonary rehabilitation at study entry will be asked to maintain their levels of rehabilitation for the duration of the study.\n* Use of any investigational therapy as part of a clinical trial for any medical condition within 30 days of study entry\n* Start or change in dose of treatment for IPF investigational agent (e.g., interferon gamma-1b, pirfenidone, etanercept, N-acetylcysteine, any other investigational agent intended to treat IPF), corticosteroids, or cytotoxic agents within 30 days of study entry\n* Use of certain medications. More information about this criterion can be found in the study protocol.\n* Treatment for pulmonary hypertension with prostaglandins (e.g., epoprostenol, treprostinil), endothelin-1 antagonists (e.g., bosentan, sitaxsentan, ambrisentan), or any other phosphodiesterase inhibitor (e.g., tadalafil, vardenafil) within 30 days of study entry\n* Addition or discontinuation of calcium channel blockers, digitalis, diuretics, or vasodilators within 30 days of study entry (dosage must be stable for 7 days prior to study entry \\[except for diuretics\\])\n* Currently on the waiting list for a lung transplant\n* Use of L-arginine supplements\n* Use of grapefruit juice or St. John's wort\n* Pregnant or breastfeeding\n* Resting saturation of peripheral oxygen (SpO2) (i.e., oxygen saturation measured using pulse oximetry) less than 92% with 6 liters of supplemental oxygen"}, 'identificationModule': {'nctId': 'NCT00517933', 'acronym': 'STEP-IPF', 'briefTitle': 'Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'Pro00018538'}, 'secondaryIdInfos': [{'id': 'U10HL080413', 'link': 'https://reporter.nih.gov/quickSearch/U10HL080413', 'type': 'NIH'}, {'id': '507'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sildenafil', 'description': '20 mg of sildenafil 3 times a day (TID) for 12 weeks followed by 20 mg of sildenafil TID for an additional 12 weeks', 'interventionNames': ['Drug: Sildenafil Citrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo / Sildanafil', 'description': '20 mg of placebo TID for 12 weeks followed by 20 mg of sildenafil citrate TID for an additional 12 weeks', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Sildenafil Citrate', 'type': 'DRUG', 'otherNames': ['Revatio'], 'description': 'Sildenafil citrate (20mg 3 times a day \\[TID\\] orally for 12 weeks followed by 20mg TID open-label sildenafil for an additional 12 weeks)', 'armGroupLabels': ['Sildenafil']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo (20mg TID orally for 12 weeks followed by 20mg open-label sildenafil for 12 weeks)', 'armGroupLabels': ['Placebo / Sildanafil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama - Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California - San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Medical and Research Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College of Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98165', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Gary Hunninghake, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Iowa'}, {'name': 'Kevin Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Jewish Health'}, {'name': 'Rob Kaner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College at Cornell University'}, {'name': 'Talmadge King, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Joe Lasky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University'}, {'name': 'James Loyd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}, {'name': 'Fernando Martinez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Imre Noth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}, {'name': 'Ganesh Raghu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Jesse Roman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Jay Ryu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'David Zisman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Kevin Anstrom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Herbert Reynolds, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}, {'name': 'Lake D Morrison, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}