Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01552902
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2012-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Belgium', 'Colombia', 'France', 'India', 'Israel', 'Italy', 'Netherlands', 'New Zealand', 'Poland', 'Romania', 'Spain', 'Turkey (Türkiye)', 'United Kingdom']}, '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': 'D000069478', 'term': 'Lisdexamfetamine Dimesylate'}, {'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D003913', 'term': 'Dextroamphetamine'}, {'id': 'D000661', 'term': 'Amphetamine'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': {'timeFrame': 'Baseline up to 3 days after last dose (last dose at Week 6)', 'description': 'AEs occurred during the double-blind evaluation phase were considered as TEAEs if AEs had a start date on or after the first dose of double-blind study drug or a start date before the date of the first dose of double-blind study drug, but increased in severity on or after the date of the first dose of double-blind study drug. Safety Set.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '2 placebo over encapsulated capsules once daily orally for 6 weeks.', 'otherNumAtRisk': 110, 'otherNumAffected': 32, 'seriousNumAtRisk': 110, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).', 'otherNumAtRisk': 218, 'otherNumAffected': 113, 'seriousNumAtRisk': 218, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Methylphenidate', 'description': 'Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg \\[2\\*36 mg capsules\\] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2\\*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).', 'otherNumAtRisk': 219, 'otherNumAffected': 99, 'seriousNumAtRisk': 219, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 45, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 40, 'numAffected': 35}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 74, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 52, 'numAffected': 51}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Psychotic episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo over encapsulated capsules once daily orally for 6 weeks.'}, {'id': 'OG001', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).'}, {'id': 'OG002', 'title': 'Methylphenidate', 'description': 'Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg \\[2\\*36 mg capsules\\] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2\\*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).'}], 'classes': [{'categories': [{'measurements': [{'value': '-17', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-25.4', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '-22.1', 'spread': '0.73', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.0013', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '-1.3', 'groupDescription': 'The least squares mean (LSM), the difference in LSM and its 95% confidence interval (CI), and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on Restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.5', 'ciLowerLimit': '-11', 'ciUpperLimit': '-6', 'groupDescription': 'The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.1', 'ciLowerLimit': '-7.6', 'ciUpperLimit': '-2.6', 'groupDescription': 'The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that includes treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) was defined as all participants in the Safety set who had at least 1 post-baseline measurement of the ADHD-RS-IV. Not all FAS participants were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo over encapsulated capsules once daily orally for 6 weeks.'}, {'id': 'OG001', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).'}, {'id': 'OG002', 'title': 'Methylphenidate', 'description': 'Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg \\[2\\*36 mg capsules\\] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2\\*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '81.4', 'groupId': 'OG001'}, {'value': '71.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': "The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo over encapsulated capsules once daily orally for 6 weeks.'}, {'id': 'OG001', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).'}, {'id': 'OG002', 'title': 'Methylphenidate', 'description': 'Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg \\[2\\*36 mg capsules\\] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2\\*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}]}, {'title': 'Participants with serious TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 3 days after last dose (last dose at Week 6)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Blood Pressure at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo over encapsulated capsules once daily orally for 6 weeks.'}, {'id': 'OG001', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).'}, {'id': 'OG002', 'title': 'Methylphenidate', 'description': 'Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg \\[2\\*36 mg capsules\\] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2\\*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '-1', 'spread': '9.88', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '9.56', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '9.97', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '8.15', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '8.59', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set. Not all Safety set participants were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Pulse Rate at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo over encapsulated capsules once daily orally for 6 weeks.'}, {'id': 'OG001', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).'}, {'id': 'OG002', 'title': 'Methylphenidate', 'description': 'Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg \\[2\\*36 mg capsules\\] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2\\*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '10.81', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '12.46', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '12.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set. Not all Safety set participants were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '2 placebo over encapsulated capsules once daily orally for 6 weeks.'}, {'id': 'FG001', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 milligram (mg) over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).'}, {'id': 'FG002', 'title': 'Methylphenidate', 'description': 'Methylphenidate (Concerta, Osmotic controlled oral release delivery system-methylphenidate \\[OROS-MPH\\]) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg \\[2\\*36 mg capsules\\] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2\\*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '218'}, {'groupId': 'FG002', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '181'}, {'groupId': 'FG002', 'numSubjects': '186'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was conducted at 77 sites in the United States, Canada, and Europe.', 'preAssignmentDetails': "Of the 778 screened participants, 229 were screen failures and 549 were randomized to treatment. A total of 547 participants were treated and the reasons for 2 'randomized but not treated' participants included withdrawal by 1 participant in the Methylphenidate group and 1 participant with a protocol violation in the Lisdexamfetamine group."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}, {'value': '547', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '2 placebo over encapsulated capsules once daily orally for 6 weeks.'}, {'id': 'BG001', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).'}, {'id': 'BG002', 'title': 'Methylphenidate', 'description': 'Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg \\[2\\*36 mg capsules\\] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2\\*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}, {'value': '547', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age was calculated as the difference between date of birth and date of informed consent.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '1.37', 'groupId': 'BG000'}, {'value': '14.6', 'spread': '1.38', 'groupId': 'BG001'}, {'value': '14.7', 'spread': '1.42', 'groupId': 'BG002'}, {'value': '14.7', 'spread': '1.40', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Age was calculated as the difference between date of birth and date of informed consent.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '361', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Attention-deficit/Hyperactivity Disorder (ADHD) Subtype', 'classes': [{'title': 'Predominantly Inattentive', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}]}, {'title': 'Predominantly Hyperactive/Impulsive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Combined Subtype', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '358', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical Global Impressions - Severity of Illness (CGI-S)', 'classes': [{'title': 'Borderline mentally ill', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Mildly ill', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Moderately ill', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}]}, {'title': 'Markedly ill', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '237', 'groupId': 'BG003'}]}]}, {'title': 'Severely ill', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale includes a severity of illness item and a global improvement item. The investigator performed the CGI-S to rate the severity of a participant's condition on a 7-point scale (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill).", 'unitOfMeasure': 'Participants'}, {'title': 'Attention-deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '5.91', 'groupId': 'BG000'}, {'value': '37.2', 'spread': '6.46', 'groupId': 'BG001'}, {'value': '36.9', 'spread': '6.42', 'groupId': 'BG002'}, {'value': '36.9', 'spread': '6.34', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety set consisted of all participants in the Randomized set (all screened participants for whom a randomization number was generated) who took at least 1 dose of investigational product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 549}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2014-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-29', 'studyFirstSubmitDate': '2012-03-06', 'resultsFirstSubmitDate': '2015-03-04', 'studyFirstSubmitQcDate': '2012-03-09', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-04', 'studyFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'Baseline up to 3 days after last dose (last dose at Week 6)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Change From Baseline in Blood Pressure at Week 6', 'timeFrame': 'Baseline, Week 6'}, {'measure': 'Change From Baseline in Pulse Rate at Week 6', 'timeFrame': 'Baseline, Week 6'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6', 'timeFrame': 'Week 6', 'description': "The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD'], 'conditions': ['Attention-deficit/Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '28980198', 'type': 'DERIVED', 'citation': 'Newcorn JH, Nagy P, Childress AC, Frick G, Yan B, Pliszka S. Randomized, Double-Blind, Placebo-Controlled Acute Comparator Trials of Lisdexamfetamine and Extended-Release Methylphenidate in Adolescents With Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2017 Nov;31(11):999-1014. doi: 10.1007/s40263-017-0468-2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be 13-17 years of age, inclusive, at the time of consent.\n* Subject must weigh more than 79.5lb.\n* The parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration.\n* Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.\n* Subject has an ADHD-RS-IV total score ≥28.\n* Subject is able to swallow a capsule.\n* Subject does not have hypertension and has a resting sitting blood pressure less than or equal to 135/85mmHg.\n\nExclusion Criteria\n\n* Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder.\n* Diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.\n* Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded.\n* Subject is underweight or overweight.\n* Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition. Mild, stable asthma is not exclusionary.\n* Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.\n* Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her at increased vulnerability to the sympathomimetic effects of a stimulant medication.\n* Subject has a known family history of sudden cardiac death or ventricular arrhythmia.\n* Subject has any clinically significant ECG or clinically significant laboratory abnormality.\n* Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.\n* Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.\n* Subject has a documented allergy, hypersensitivity, or intolerance to MPH or to any excipients in the reference product.\n* Subject has failed to fully respond to an adequate course(s) (dose and duration) of MPH or amphetamine therapy.\n* Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine). Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.\n* Subject has a positive urine drug result.\n* Subject has previously participated in this study or another clinical study involving SPD489/NRP104.\n* Subject has glaucoma.\n* Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.\n* Subject is female and is pregnant or lactating.\n* Subject is well controlled on his/her current ADHD medication.\n* Subject has a pre-existing severe gastrointestinal tract narrowing."}, 'identificationModule': {'nctId': 'NCT01552902', 'briefTitle': 'Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'SPD489-406'}, 'secondaryIdInfos': [{'id': '2011-005452-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lisdexamfetamine dimesylate', 'interventionNames': ['Drug: Lisdexamfetamine dimesylate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylphenidate Hydrochloride', 'interventionNames': ['Drug: Methylphenidate Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lisdexamfetamine dimesylate', 'type': 'DRUG', 'otherNames': ['SPD489, Vyvanse, LDX'], 'description': 'Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance', 'armGroupLabels': ['Lisdexamfetamine dimesylate']}, {'name': 'Methylphenidate Hydrochloride', 'type': 'DRUG', 'otherNames': ['Concerta, OROS-MPH'], 'description': 'Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance', 'armGroupLabels': ['Methylphenidate Hydrochloride']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Daily oral dosing in the AM for 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36303', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Harmonex Neuroscience Research, Inc.', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Center for Advanced Improvement', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Study Centers, LLC', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92324', 'city': 'Colton', 'state': 'California', 'country': 'United States', 'facility': 'Shanti Clinical Trials', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '92251', 'city': 'Imperial', 'state': 'California', 'country': 'United States', 'facility': 'Sun Valley Research Center', 'geoPoint': {'lat': 32.84755, 'lon': -115.56944}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Clinical Research Center', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '92054', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Sleep Medicine, A Medical Corporation', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Neuropsychiatric Research Center for Orange County', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Peninsula Research Associates', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'PCSD - Feighner Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'Encompass Clinical Research', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '92595', 'city': 'Wildomar', 'state': 'California', 'country': 'United States', 'facility': 'Elite Clinical Trials', 'geoPoint': {'lat': 33.59891, 'lon': -117.28004}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'IMMUNOe International Research Center', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'MCB Clinical Research Centers, LLC', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Coastal Connecticut Research, LLC', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center, LLC', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33013', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Amedica Research Institute, Inc', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32055', 'city': 'Lake City', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarkis Clinical Trials', 'geoPoint': {'lat': 30.18968, 'lon': -82.63929}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center, LLC', 'geoPoint': {'lat': 28.62778, 'lon': 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