Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT00485550
Status:
COMPLETED
Last Update Posted:
2007-06-13
First Post:
2007-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy
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'}, {'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2005-03', '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': 'Assess the safety of atomoxetine and placebo compared to atomoxetine and methylphenidate in children aged 6 through 12 years with ADHD who have been identified as stimulant non-responders and have been exposed to acute treatment of atomoxetine.'}], 'secondaryOutcomes': [{'measure': 'Assess the safety of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by ECGs'}, {'measure': 'Assess the safety of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by clinical laboratory tests'}, {'measure': 'Assess the tolerability of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children retrospectively identified as stimulant non-responders as measured by spontaneously reported AEs'}, {'measure': 'Compare the efficacy of atomoxetine and placebo as compared to atomoxetine and methylphenidate for the treatment of ADHD in children'}]}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of atomoxetine alone versus atomoxetine plus low-dose, sustained-release MPH in children with treatment-resistant ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients will be at least 6 years of age and not more than 12 years of age at visit 1\n* Patients must meet DSM-IV diagnostic criteria for ADHD\n* Patients must be retrospectively identified as stimulant non-responders\n* Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on an IQ test)\n* Patients must be able to swallow capsules\n\nExclusion Criteria:\n\n* Patients who weigh less than 22 kg or more than 60 kg at study entry\n* Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or pervasive developmental disorder\n* Patients who meet DSM-IV criteria for anxiety disorder or autism\n* Patients with a history of any seizure disorder and/or Rolandic seizures (other than febrile seizures) or prior electroencephalogram (ECG) abnormalities in the absence of seizures, or patients who have taken (or are currently taking) anticonvulsants for seizure control\n* Patients with a history of severe allergies to more than one class of medication or multiple adverse drug reactions, including hypersensitivity to MPH"}, 'identificationModule': {'nctId': 'NCT00485550', 'briefTitle': "Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride Augmented With Either Extended-Release Methylphenidate Hydrochloride (Concerta-TM) or Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Not Responded to Stimulant Mono Therapy', 'orgStudyIdInfo': {'id': '7065'}, 'secondaryIdInfos': [{'id': 'B4Z-MC-LYBU'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Atomoxetine Hydrochloride', 'type': 'DRUG'}, {'name': 'Methylphenidate Hydrochloride', 'type': 'DRUG'}, {'name': 'Placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', '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': 33.50921, 'lon': -111.89903}}], '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'}}}}