Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-07 @ 11:01 PM
Study NCT ID:
NCT00557960
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2007-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C449521', 'term': 'SLI381'}, {'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2004-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2007-11-09', 'studyFirstSubmitQcDate': '2007-11-12', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Driving Safety Score derived by the driving simulator', 'timeFrame': 'Weeks 3 & 6'}], 'secondaryOutcomes': [{'measure': 'Driving Safety Scores at individual time points', 'timeFrame': '2, 7, and 12 hours post-dose at Weeks 3 & 6'}, {'measure': 'Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire', 'timeFrame': 'Weeks 3 & 6'}, {'measure': 'AEs, laboratory screens, PE, vital signs, ECG', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'referencesModule': {'references': [{'pmid': '18815438', 'type': 'RESULT', 'citation': 'Kay GG, Michaels MA, Pakull B. Simulated driving changes in young adults with ADHD receiving mixed amphetamine salts extended release and atomoxetine. J Atten Disord. 2009 Jan;12(4):316-29. doi: 10.1177/1087054708322986. Epub 2008 Sep 24.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'FDA Recall Information'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* primary diagnosis of ADHD\n* not naive to pharmacologic ADHD treatment\n* valid driver's license with a minimum of 3 years driving experience\n\nExclusion Criteria:\n\n* recent history of drug dependence or substance use disorder\n* any specific cardiac condition that would, in the opinion of the investigator, require exclusion\n* history of seizure in last 2 years, tic disorder or Tourette's disorder\n* female subject is pregnant or lactating"}, 'identificationModule': {'nctId': 'NCT00557960', 'briefTitle': 'ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With ADDERALL XR and STRATTERA Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With Attention Deficit Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'SLI381-316'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mixed salts of a single-entity amphetamine', 'type': 'DRUG', 'otherNames': ['ADDERALL XR']}, {'name': 'Atomoxetine hydrochloride', 'type': 'DRUG', 'otherNames': ['STRATTERA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Neuropsychological Institute, LLC', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}