Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-28 @ 5:13 PM
Study NCT ID:
NCT00485459
Status:
COMPLETED
Last Update Posted:
2007-06-13
First Post:
2007-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents 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': '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': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-11', 'studyFirstSubmitDate': '2007-06-11', 'studyFirstSubmitQcDate': '2007-06-11', 'lastUpdatePostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD'}], 'secondaryOutcomes': [{'measure': 'Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo'}, {'measure': 'Compare the reduction in school-related symptoms between atomoxetine and placebo'}, {'measure': 'Assess the safety and tolerability of once-daily dosing of atomoxetine'}]}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '25019647', 'type': 'DERIVED', 'citation': 'Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria\n* Subjects must be aged 6 to 16 years\n* Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures\n* Subjects must be able to swallow capsules\n* Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.\n\nExclusion Criteria:\n\n* Weigh less than 20 kg or more than 60 kg at study entry\n* Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder\n* Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator\n* Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control\n* Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.'}, 'identificationModule': {'nctId': 'NCT00485459', 'briefTitle': 'Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With Attention-Deficit/Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '8160'}, 'secondaryIdInfos': [{'id': 'B4Z-TW-S010'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Atomoxetine Hydrochloride', 'type': 'DRUG'}, {'name': 'Placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}