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- Essai clinique NCT00471354
A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
4 janvier 2010 mis à jour par: Eli Lilly and Company
Evaluation of Academic Performance in Asian Children Aged 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine Hydrochloride
The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
228
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing, Chine, 100088
- 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 ph
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Shanghai, Chine, 200127
- 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 ph
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Pusan, Corée, République de, 609-739
- 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 ph
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Seoul, Corée, République de, 138-736
- 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 ph
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Neihu Taipei, Taïwan, 114
- 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 ph
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Niao Sung Hsiang, Taïwan, 833
- 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 ph
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Taipei, Taïwan, 100
- 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 ph
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Tao-Yuan, Taïwan, 333
- 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 ph
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
8 ans à 11 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Male or female outpatients between 8 and 11 years of age at study entry
- Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria
- Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
- Normal intelligence in the judgment of the investigator
- Must be able to swallow capsules
Exclusion Criteria:
- Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
- History of seizure disorder or currently taking anticonvulsants for seizure control
- Serious suicidal risk as determined by investigator
- Cardiovascular disease; current or past history of hypertension
- Previous treatment with atomoxetine
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Atomoxetine
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
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atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)
Délai: Baseline, 24 weeks
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Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score.
ADHD-RS measures 18 symptoms associated with diagnosis of ADHD.
Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often).
Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude.
Any ordinal grades were imputed to numerical grades based on communication with relevant schools.
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Baseline, 24 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes
Délai: Baseline, 24 weeks
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Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores.
ADHD-RS measures 18 symptoms associated with diagnosis of ADHD.
Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often).
Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class.
Any ordinal grades were imputed to numerical grades based on communication with relevant schools.
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Baseline, 24 weeks
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Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores
Délai: Baseline, 24 weeks
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Separate school grades in the classes of Language, Math, and Science were obtained.
A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall.
Any ordinal grades were imputed to numerical grades based on communication with relevant schools.
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Baseline, 24 weeks
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Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score
Délai: Baseline, 24 weeks
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Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder.
Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often).
Total scores range from 0 to 54.
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Baseline, 24 weeks
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Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)
Délai: Baseline, 24 weeks
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Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
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Baseline, 24 weeks
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CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint
Délai: 24 weeks
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Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).
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24 weeks
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Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score
Délai: Baseline, 24 weeks
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A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD.
Subscale assessed: ADHD Index.
ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27.
Subscale total scores range from 0 to 36.
Higher scores reflect more severe problem behaviors related to ADHD.
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Baseline, 24 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2007
Achèvement primaire (Réel)
1 novembre 2008
Achèvement de l'étude (Réel)
1 novembre 2008
Dates d'inscription aux études
Première soumission
7 mai 2007
Première soumission répondant aux critères de contrôle qualité
7 mai 2007
Première publication (Estimation)
9 mai 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
12 janvier 2010
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 janvier 2010
Dernière vérification
1 janvier 2010
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Maladies du système nerveux
- Manifestations neurologiques
- Dyskinésies
- Déficit de l'attention et troubles du comportement perturbateur
- Troubles neurodéveloppementaux
- Trouble déficitaire de l'attention avec hyperactivité
- Hyperkinésie
- Effets physiologiques des médicaments
- Agents adrénergiques
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs de l'absorption des neurotransmetteurs
- Modulateurs de transport membranaire
- Inhibiteurs de l'absorption adrénergique
- Chlorhydrate d'atomoxétine
Autres numéros d'identification d'étude
- 11098
- B4Z-CR-S018
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .