Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-06 @ 1:59 AM
Study NCT ID:
NCT01280266
Status:
COMPLETED
Last Update Posted:
2012-12-11
First Post:
2011-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011928', 'term': 'Raynaud Disease'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D000090122', 'term': 'Livedoid Vasculopathy'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C419664', 'term': 'udenafil'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'leb7616@snu.ac.kr', 'phone': '+82 2 2072-3944', 'title': 'Dr. Eun Bong Lee', 'organization': 'Seoul National University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During 8 weeks while taking a study drug.', 'description': 'As a cross over trial, study participants received both amlodipine and udenafil following each other.', 'eventGroups': [{'id': 'EG000', 'title': 'Amlodipine', 'description': 'Adverse effects observed while taking amlodipine in both study arms', 'otherNumAtRisk': 26, 'otherNumAffected': 14, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Udenafil', 'description': 'Adverse effects observed while taking udenafil in both study arms', 'otherNumAtRisk': 26, 'otherNumAffected': 19, 'seriousNumAtRisk': 26, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Facial flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Facial edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'RP Attacks Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Changes in RP attacks per day during amlodipine 10 mg orally per day'}, {'id': 'OG001', 'title': 'Udenafil', 'description': 'Changes in RP attacks per day during udenafil 100mg orally per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baselin and 4 weeks', 'description': 'Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.', 'unitOfMeasure': 'attacks per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 patients in UA arm + 12 patients in AU arm'}, {'type': 'SECONDARY', 'title': "Change in Raynaud's Condition Score (RCS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Changes in RPS during amlodipine 100 mg orally per day'}, {'id': 'OG001', 'title': 'Udenafil', 'description': 'Changes in RPS during udenafil 10 mg orally per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': "change in the RCS. RCS combines daily activty, frequency, duration and severity as well as impact of RP attack (Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon, Merkel et al,Arthritis Rheum. 2002 Sep;46(9):2410-20).\n\nRange 0-10 ordinal scale 0..good 10.. bad", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the RP Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Drug: amlodipine 100 mg p.o. per day'}, {'id': 'OG001', 'title': 'Udenafil', 'description': 'Drug: udenafil 10 mg p.o. per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '11.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': 'Change in the average RP duration in minutes (min) per attack. 0 -- unlimited', 'unitOfMeasure': 'min per attack', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Health Assessment Questionnaire (HAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Drug: amlodipine 100 mg p.o. per day'}, {'id': 'OG001', 'title': 'Udenafil', 'description': 'Drug: udenafil 10 mg p.o. per day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 and 4 weeks', 'description': 'Ordinal scale 0-10 0 good 10 bad', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Physician's Global Assessment on Visual Analogue Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Drug: amlodipine 100 mg p.o. per day'}, {'id': 'OG001', 'title': 'Udenafil', 'description': 'Drug: udenafil 10 mg p.o. per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 0 (baseline) and 4 weeks (after treatment)', 'description': "Physician's global assessment (PGA) on VAS assesses the overall condition of the patient. The scale ranges from 0 - 10, with 0 being good and 10 bad. As such, change in the GPA measures the change in the patient's condition from the baseline.\n\nnegative value (decrease in value) means improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Digital Ulcer Number', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Drug: amlodipine 100 mg p.o. per day'}, {'id': 'OG001', 'title': 'Udenafil', 'description': 'Drug: udenafil 10 mg p.o. per day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': '0 - unlimited. Number of digital ulcers in all fingers are counted by the investigators and recorded at each visit. The number of ulcers in all fingers indirectly reflect the extent of critical ischemia. As such. the decrease in digital ulcer number reflects positive response to treatment (=better blood flow), whereas the increase ulcer numbers indicates worsening finger ischemia from baseline.', 'unitOfMeasure': 'Digital ulcers', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Peak Systolic Flow (cm/Sec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Drug: amlodipine 100 mg p.o. per day'}, {'id': 'OG001', 'title': 'Udenafil', 'description': 'Drug: udenafil 10 mg p.o. per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.9', 'spread': '145.9', 'groupId': 'OG000'}, {'value': '63.2', 'spread': '170.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': 'Change in digital artery flow velocity in proper palmar digital artery in cm/sec.\n\n0-unlimited', 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time-averaged Peak Velocity (cm/Sec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Drug: amlodipine 100 mg p.o. per day'}, {'id': 'OG001', 'title': 'Udenafil', 'description': 'Drug: udenafil 10 mg p.o. per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.3', 'spread': '98.6', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '123', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': 'changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.', 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dorsal-digital-difference.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Drug: amlodipine 100 mg p.o. per day'}, {'id': 'OG001', 'title': 'Udenafil', 'description': 'Drug: udenafil 10 mg p.o. per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': 'The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.', 'unitOfMeasure': 'degree celcius.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amlodipine-Udenafil (AU) Arm', 'description': 'Amlodipine 10mg PO QD for 4 weeks, washout period for 1week, then Udenafil 100mg PO QD for 4 weeks.'}, {'id': 'FG001', 'title': 'Udenafil-Amlodipine (UA) Arm', 'description': 'Udenafil 100mg PO QD for 4 weeks, washout period for 1 week, then Udenafil 10mg PO QD for 4 weeks.'}], 'periods': [{'title': 'First Intervention (Week 1-4)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Washout Period (Week 4-5)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (Week 5-9)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment begin Jan 13 2011 until Mar 15 2011. Location: Rheumatology outpatient clinic at Seoul National University Hospital, Seoul, Korea.', 'preAssignmentDetails': '30 Patients were initially recruited, but an error occurred in obtaining informed consent and this one was withdrawn.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Amlodipine-Udenafil (AU) Arm', 'description': 'Amlodipine first, then Udenafil'}, {'id': 'BG001', 'title': 'Udenafil-Amlodipine (UA) Arm', 'description': 'Udenafil first, then Amlodipine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '52.3', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '50.9', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease subtype', 'classes': [{'title': 'Localized systemic sclerosis (SSc)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'diffuse SSc', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Mixed connective tissue disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': "Sjogren's disease", 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Underlying rheumatic disease', 'unitOfMeasure': 'participant'}, {'title': 'RP duration', 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '5.6', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '7.3', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prior use of vasodilator', 'classes': [{'title': 'calcium channel blocker', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'angiotensin receptor blocker', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Pentyxifylline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'No prior use', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-07', 'studyFirstSubmitDate': '2011-01-14', 'resultsFirstSubmitDate': '2012-07-04', 'studyFirstSubmitQcDate': '2011-01-19', 'lastUpdatePostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-07', 'studyFirstPostDateStruct': {'date': '2011-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RP Attacks Per Day', 'timeFrame': 'baselin and 4 weeks', 'description': 'Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.'}], 'secondaryOutcomes': [{'measure': "Change in Raynaud's Condition Score (RCS)", 'timeFrame': 'baseline and 4 weeks', 'description': "change in the RCS. RCS combines daily activty, frequency, duration and severity as well as impact of RP attack (Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon, Merkel et al,Arthritis Rheum. 2002 Sep;46(9):2410-20).\n\nRange 0-10 ordinal scale 0..good 10.. bad"}, {'measure': 'Change in the RP Duration', 'timeFrame': 'baseline and 4 weeks', 'description': 'Change in the average RP duration in minutes (min) per attack. 0 -- unlimited'}, {'measure': 'Change in Health Assessment Questionnaire (HAQ)', 'timeFrame': '0 and 4 weeks', 'description': 'Ordinal scale 0-10 0 good 10 bad'}, {'measure': "Change in Physician's Global Assessment on Visual Analogue Scale (VAS)", 'timeFrame': 'at 0 (baseline) and 4 weeks (after treatment)', 'description': "Physician's global assessment (PGA) on VAS assesses the overall condition of the patient. The scale ranges from 0 - 10, with 0 being good and 10 bad. As such, change in the GPA measures the change in the patient's condition from the baseline.\n\nnegative value (decrease in value) means improvement."}, {'measure': 'Change in Digital Ulcer Number', 'timeFrame': 'baseline and 4 weeks', 'description': '0 - unlimited. Number of digital ulcers in all fingers are counted by the investigators and recorded at each visit. The number of ulcers in all fingers indirectly reflect the extent of critical ischemia. As such. the decrease in digital ulcer number reflects positive response to treatment (=better blood flow), whereas the increase ulcer numbers indicates worsening finger ischemia from baseline.'}, {'measure': 'Change in Peak Systolic Flow (cm/Sec)', 'timeFrame': 'baseline and 4 weeks', 'description': 'Change in digital artery flow velocity in proper palmar digital artery in cm/sec.\n\n0-unlimited'}, {'measure': 'Time-averaged Peak Velocity (cm/Sec)', 'timeFrame': 'baseline and 4 weeks', 'description': 'changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.'}, {'measure': 'Dorsal-digital-difference.', 'timeFrame': 'baseline and 4 weeks', 'description': 'The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.'}]}, 'conditionsModule': {'keywords': ['Pathological Conditions', 'Signs and Symptoms', 'Blood circulation'], 'conditions': ['Raynaud Phenomenon']}, 'referencesModule': {'references': [{'pmid': '24352340', 'type': 'DERIVED', 'citation': "Lee EY, Park JK, Lee W, Kim YK, Park CS, Giles JT, Park JW, Shin K, Lee JS, Song YW, Lee EB. Head-to-head comparison of udenafil vs amlodipine in the treatment of secondary Raynaud's phenomenon: a double-blind, randomized, cross-over study. Rheumatology (Oxford). 2014 Apr;53(4):658-64. doi: 10.1093/rheumatology/ket417. Epub 2013 Dec 17."}]}, 'descriptionModule': {'briefSummary': 'The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin discoloration, is 5-10% in general population. Often conventional measures such as warming up or minimizing exposure to cold are not enough and many patients require treatment with a vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil, a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.\n\nHere, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5 inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment of secondary RP in Korean patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* secondary Raynaud's phenomenon\n\nExclusion Criteria:\n\n* primary raynaud phenomenon\n* active infection\n* hypersensitivity to PDE5 inhibitor or Calcium Chanel Blocker (CCB)\n* elevated AST/ALT (3 times above the upper normal limit)\n* severe renal failure\n* patients on nitrite or nitric oxide (NO) donor treatment\n* recent history of cerebrovascular accidents, acute myocardial infarction, or coronary artery bypass surgery\n* hypotension (less than 90/50 mmHg) or uncontrolled hypertension"}, 'identificationModule': {'nctId': 'NCT01280266', 'briefTitle': 'Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial', 'orgStudyIdInfo': {'id': 'RaynaudSNUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amlodipine-Udenafil (AU) arm', 'description': 'Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks', 'interventionNames': ['Drug: Udenafil or Amlodipine']}, {'type': 'EXPERIMENTAL', 'label': 'Udenafil-Amlodipine (UA) arm', 'description': 'Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks', 'interventionNames': ['Drug: Udenafil or Amlodipine']}], 'interventions': [{'name': 'Udenafil or Amlodipine', 'type': 'DRUG', 'description': 'Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily', 'armGroupLabels': ['Amlodipine-Udenafil (AU) arm', 'Udenafil-Amlodipine (UA) arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Eun Bong Lee, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor of Seoul National University College of Medicine'}, {'name': 'Eun Young Lee, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant professor, Seoul National University College of Medicine'}, {'name': 'Jin Kyun Park, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dong-A Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Direct, Division of Rheumatology', 'investigatorFullName': 'Eun Bong Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}