Viewing Study NCT00150618

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Ignite Creation Date: 2025-12-25 @ 4:36 AM
Ignite Modification Date: 2025-12-26 @ 3:38 AM
Study NCT ID: NCT00150618
Status: COMPLETED
Last Update Posted: 2021-06-10
First Post: 2005-09-06
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016316', 'term': 'Guanfacine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SPD503 (1 mg)', 'description': 'Guanfacine HCl once daily', 'otherNumAtRisk': 61, 'otherNumAffected': 49, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SPD503 (2 mg)', 'description': 'Guanfacine HCl once daily', 'otherNumAtRisk': 65, 'otherNumAffected': 40, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SPD503 (3 mg)', 'description': 'Guanfacine HCl once daily', 'otherNumAtRisk': 65, 'otherNumAffected': 45, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'SPD503 (4 mg)', 'description': 'Guanfacine HCl once daily', 'otherNumAtRisk': 65, 'otherNumAffected': 55, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo', 'description': 'once daily', 'otherNumAtRisk': 66, 'otherNumAffected': 45, 'seriousNumAtRisk': 66, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503 (1 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG001', 'title': 'SPD503 (2 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG002', 'title': 'SPD503 (3 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG003', 'title': 'SPD503 (4 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.44', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '-18.09', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '-20.00', 'spread': '1.64', 'groupId': 'OG002'}, {'value': '-20.57', 'spread': '1.60', 'groupId': 'OG003'}, {'value': '-12.69', 'spread': '1.60', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0041', 'groupIds': ['OG000', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0176', 'groupIds': ['OG001', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0016', 'groupIds': ['OG002', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0006', 'groupIds': ['OG003', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the Baseline and at least one post-randomization primary efficacy measurement.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503 (1 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG001', 'title': 'SPD503 (2 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG002', 'title': 'SPD503 (3 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG003', 'title': 'SPD503 (4 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.50', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '-14.96', 'spread': '2.29', 'groupId': 'OG001'}, {'value': '-17.94', 'spread': '2.48', 'groupId': 'OG002'}, {'value': '-15.93', 'spread': '2.34', 'groupId': 'OG003'}, {'value': '-8.41', 'spread': '2.34', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0468', 'groupIds': ['OG001', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0056', 'groupIds': ['OG002', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0237', 'groupIds': ['OG003', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': "The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503 (1 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG001', 'title': 'SPD503 (2 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG002', 'title': 'SPD503 (3 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG003', 'title': 'SPD503 (4 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0074', 'groupIds': ['OG000', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1404', 'groupIds': ['OG001', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0055', 'groupIds': ['OG002', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0041', 'groupIds': ['OG003', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement in Parent Global Assessment (PGA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503 (1 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG001', 'title': 'SPD503 (2 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG002', 'title': 'SPD503 (3 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG003', 'title': 'SPD503 (4 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0303', 'groupIds': ['OG000', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4982', 'groupIds': ['OG001', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0017', 'groupIds': ['OG002', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0063', 'groupIds': ['OG003', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503 (1 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG001', 'title': 'SPD503 (2 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG002', 'title': 'SPD503 (3 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG003', 'title': 'SPD503 (4 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'once daily'}], 'classes': [{'title': 'Physical', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '0.99', 'groupId': 'OG002'}, {'value': '-2.44', 'spread': '0.95', 'groupId': 'OG003'}, {'value': '-0.01', 'spread': '0.92', 'groupId': 'OG004'}]}]}, {'title': 'Psychosocial', 'categories': [{'measurements': [{'value': '10.61', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '7.47', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '9.07', 'spread': '1.61', 'groupId': 'OG002'}, {'value': '9.43', 'spread': '1.53', 'groupId': 'OG003'}, {'value': '6.34', 'spread': '1.49', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0383', 'groupIds': ['OG000', 'OG004'], 'ciPctValue': '95', 'groupDescription': 'Psychosocial category', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5859', 'groupIds': ['OG001', 'OG004'], 'ciPctValue': '95', 'groupDescription': 'Psychosocial category', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2136', 'groupIds': ['OG002', 'OG004'], 'ciPctValue': '95', 'groupDescription': 'Psychosocial category', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1483', 'groupIds': ['OG003', 'OG004'], 'ciPctValue': '95', 'groupDescription': 'Psychosocial category', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SPD503 (1 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'FG001', 'title': 'SPD503 (2 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'FG002', 'title': 'SPD503 (3 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'FG003', 'title': 'SPD503 (4 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '66'}, {'groupId': 'FG004', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'No study meds', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lack of compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Abnormal ECG', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': "Sponsor's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Although 324 subjects were randomized, 2 never received drug and therefore were not included in the Baseline Characteristics. Subjects received either 1, 2, 3, or 4 mg of SPD503 (Guanfacine hydrochloride) or placebo once daily.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}, {'value': '322', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'SPD503 (1 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'BG001', 'title': 'SPD503 (2 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'BG002', 'title': 'SPD503 (3 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'BG003', 'title': 'SPD503 (4 mg)', 'description': 'Guanfacine HCl once daily'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'once daily'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}, {'value': '322', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '2.14', 'groupId': 'BG000'}, {'value': '10.6', 'spread': '2.81', 'groupId': 'BG001'}, {'value': '11.1', 'spread': '2.96', 'groupId': 'BG002'}, {'value': '10.5', 'spread': '2.53', 'groupId': 'BG003'}, {'value': '10.8', 'spread': '2.89', 'groupId': 'BG004'}, {'value': '10.5', 'spread': '2.74', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '89', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '233', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}, {'value': '322', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2004-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-29', 'studyFirstSubmitDate': '2005-09-06', 'resultsFirstSubmitDate': '2009-09-10', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-09-11', 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.'}], 'secondaryOutcomes': [{'measure': "Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks", 'timeFrame': 'Baseline and 6 weeks', 'description': "The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior."}, {'measure': 'Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)', 'timeFrame': '6 weeks', 'description': 'Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.'}, {'measure': 'Number of Participants With Improvement in Parent Global Assessment (PGA)', 'timeFrame': '6 weeks', 'description': 'Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.'}, {'measure': 'Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.'}]}, 'conditionsModule': {'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'referencesModule': {'references': [{'pmid': '19106767', 'type': 'RESULT', 'citation': 'Sallee FR, McGough J, Wigal T, Donahue J, Lyne A, Biederman J; SPD503 STUDY GROUP. Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009 Feb;48(2):155-65. doi: 10.1097/CHI.0b013e318191769e.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'FDA recall information'}, {'url': 'http://www.intuniv.com/documents/INTUNIV_Full_Prescribing_Information.pdf', 'label': 'FDA-approved label'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with a primary diagnosis of ADHD\n* Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test\n* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements\n\nExclusion Criteria:\n\n* Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders\n* Subject weighs less than 55 lbs or is morbidly overweight with a BMI =\\> 35\n* Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder\n* Subject is pregnant or lactating"}, 'identificationModule': {'nctId': 'NCT00150618', 'briefTitle': 'Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'SPD503-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPD503 (Guanfacine HCl) (1 mg)', 'interventionNames': ['Drug: SPD503 (1 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'SPD503 (2 mg)', 'interventionNames': ['Drug: SPD503 (2 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'SPD503 (3 mg)', 'interventionNames': ['Drug: SPD503 (3 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'SPD503 (4 mg)', 'interventionNames': ['Drug: SPD503 (4 mg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SPD503 (1 mg)', 'type': 'DRUG', 'otherNames': ['Guanfacine hydrochloride'], 'armGroupLabels': ['SPD503 (Guanfacine HCl) (1 mg)']}, {'name': 'SPD503 (2 mg)', 'type': 'DRUG', 'armGroupLabels': ['SPD503 (2 mg)']}, {'name': 'SPD503 (3 mg)', 'type': 'DRUG', 'armGroupLabels': ['SPD503 (3 mg)']}, {'name': 'SPD503 (4 mg)', 'type': 'DRUG', 'armGroupLabels': ['SPD503 (4 mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}