Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

A Long Term Follow-Up Study for Asian Adult Patients With Attention Deficit Hyperactivity Disorder

15 novembre 2012 aggiornato da: Eli Lilly and Company

Long-Term, Open-Label Safety and Efficacy Study of Atomoxetine Hydrochloride in Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to assess long-term safety and tolerability in adult patients who have completed a previous atomoxetine study.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

211

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Giappone
      • Aichi, Giappone, 466-8560
        • 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.
      • Chiba, Giappone, 260-0842
        • 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.
      • Fukushima, Giappone, 960-1295
        • 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.
      • Hokkaido, Giappone, 060-0814
        • 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.
      • Hyogo, Giappone, 661-0002
        • 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.
      • Kanagawa, Giappone, 259-1193
        • 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.
      • Kumamoto, Giappone, 862-0920
        • 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.
      • Kyoto, Giappone, 606-8397
        • 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.
      • Nara, Giappone, 634-8522
        • 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.
      • Osaka, Giappone, 590-0947
        • 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.
      • Saitama, Giappone, 330-0081
        • 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.
      • Tokyo, Giappone, 170-0002
        • 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.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients who have completed the B4Z-JE-LYEE study (NCT00962104) and signed the Informed Consent Document (ICD).
  • Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture and examinations, required by the protocol.
  • Patients must possess an educational level and degree of understanding of the language of their country that enables them to communicate suitably with the investigator and study coordinator.

Exclusion Criteria:

  • Patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for current anxiety disorder and also patients who require anti-anxiety drug therapy within previous study except for those taking benzodiazepines analogs for anxiety. The dosage of diazepam equivalents should not be more than 5 milligrams/day (mg/day).
  • Patients who, in the opinion of the investigator, are at serious suicidal risk or serious risk of harming others, or whose score for Item 11 on the Hamilton Depression Rating Scale-17 items is equal or more than 2 at randomization or screening.
  • Patients with significant medical conditions that are likely to become unstable during the trial or would likely be destabilized by treatment with atomoxetine or require treatment with excluded medications.
  • Patients with a history of allergy to atomoxetine, severe allergies to more than 1 class of medications, or multiple adverse drug reactions.
  • Patients who have received treatment within the past 30 days with a drug that has not received regulatory approval for any indication at the time the informed consent document is obtained.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Atomoxetina
Droga: Atomoxetine
40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
Altri nomi:
  • LY139603
  • Strattera

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Number of Participants With Adverse Events Leading to Discontinuation
Lasso di tempo: Baseline through 48 weeks
Baseline through 48 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline to 48 Weeks Endpoint in the Conners' Adult Attention-Deficit Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version-Japanese (CAARS-Inv:SV-J)
Lasso di tempo: Baseline, 48 weeks
CAARS-Inv:SV-J is a 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and attention deficit hyperactivity disorder (ADHD) Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention subscales (scores range from 0-27) and hyperactivity/impulsivity subscales (scores range from 0-27) with a total score range of 0-54. The ADHD Index scores range from 0-36. Higher scores indicate greater impairment.
Baseline, 48 weeks
Mean Change From Baseline to 48 Weeks Endpoint in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL)-29 Scores
Lasso di tempo: Baseline, 48 weeks
AAQoL is a 29 items participant completed questionnaire rated on a 5-point Likert scale from 1 (Not at all/ Never) to 5 (Extremely/Very Often). AAQoL total (all 29 items) and 4 subscale scores: Life Productivity (11 items); Psychological Health (6 items); Life Outlook (7 items); Relationships (5 items). Total score is computed by (1) reversing scores for all items except the 7 items in the Life Outlook subscale; (2) transforming scores to 0-100 scale (1=0; 2=25; 3=50; 4=75; 5=100); (3) summing item scores and dividing by the item count. Higher total scores indicate better quality of life.
Baseline, 48 weeks
Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report )
Lasso di tempo: Baseline, 48 weeks
A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75- 225 total score). Behavioral regulation subscale measures participant's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment.
Baseline, 48 weeks
Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Anxiety Symptoms, as Measured by Hamilton Anxiety Rating Scale-14 (HAMA-14) Items
Lasso di tempo: Baseline, 48 weeks
The HAMA-14 instrument consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. This instrument is completed by the clinician based on his or her assessment of the participant. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score is the sum of the 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate greater anxiety.
Baseline, 48 weeks
Mean Change From Baseline to 48 Weeks Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)
Lasso di tempo: Baseline, 48 weeks
The CGI-ADHD-S is a single-item rating of the clinician's assessment of the overall severity of the participant's ADHD symptoms in relation to the clinician's total experience with ADHD participants. CGI-ADHD-S measures severity of the participant's overall severity of ADHD symptoms: 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Baseline, 48 weeks
Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) Version: Informant Scores (BRIEF-A:Informant Scores)
Lasso di tempo: Baseline, 48 weeks
Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75-225 total score). Behavioral regulation subscale measures participant's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment.
Baseline, 48 weeks
Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Depressive Symptoms, as Measured by Hamilton Depression Rating Scale-17 (HAMD-17) Items
Lasso di tempo: Baseline, 48 weeks
The HAMD-17 instrument consists of 17 items used to assess the severity of depression and its improvement during the course of therapy. This instrument is completed by the clinician based on his or her assessment of the participant. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). The total score is the sum of the scores from HAMD-17 Items 1 through 17 and ranges from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate greater symptom severity.
Baseline, 48 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eli Lilly and Company

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2009

Completamento primario (Effettivo)

1 gennaio 2012

Completamento dello studio (Effettivo)

1 gennaio 2012

Date di iscrizione allo studio

Primo inviato

31 agosto 2009

Primo inviato che soddisfa i criteri di controllo qualità

31 agosto 2009

Primo Inserito (Stima)

1 settembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 dicembre 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 novembre 2012

Ultimo verificato

1 novembre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 12397
  • B4Z-JE-LYEK (Altro identificatore: Eli Lilly and Company)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Denmark

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi