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Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

2 marzo 2021 aggiornato da: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Six Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Termination Reason: On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

284

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

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • Pfizer Investigational Site
  • Federazione Russa
      • Kazan, Federazione Russa, 420012
        • Pfizer Investigational Site
      • Khotkovo, Moscow Region, Federazione Russa, 142601
        • Pfizer Investigational Site
      • Lipetsk Region, Federazione Russa, 399313
        • Pfizer Investigational Site
      • Moscow, Federazione Russa, 115522
        • Pfizer Investigational Site
      • Moscow, Federazione Russa, 107076
        • Pfizer Investigational Site
      • Moscow, Federazione Russa, 117152
        • Pfizer Investigational Site
      • Moscow, Federazione Russa, 127473
        • Pfizer Investigational Site
      • Moscow, Federazione Russa, 143300
        • Pfizer Investigational Site
      • Nizhniy Novgorod, Federazione Russa, 603155
        • Pfizer Investigational Site
      • Saratov, Federazione Russa, 410012
        • Pfizer Investigational Site
      • Saratov, Federazione Russa, 410060
        • Pfizer Investigational Site
      • St. Petersburg, Federazione Russa, 192019
        • Pfizer Investigational Site
      • Tver, Federazione Russa, 170005
        • Pfizer Investigational Site
      • Yaroslavl, Federazione Russa, 150003
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Vijaywada, Andhra Pradesh, India, 520 002
        • Pfizer Investigational Site
    • Andra Pradesh/India
      • Visakhapatnam, Andra Pradesh/India, India, 530 017
        • Pfizer Investigational Site
    • Guj
      • Ahmedabad, Guj, India, 380015
        • Pfizer Investigational Site
    • Karnataka
      • Mangalore, Karnataka, India, 575001
        • Pfizer Investigational Site
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431 005
        • Pfizer Investigational Site
      • Mumbai, Maharashtra, India, 400 058
        • Pfizer Investigational Site
      • Pune, Maharashtra, India, 411 001
        • Pfizer Investigational Site
      • Pune, Maharashtra, India, 411 046
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Pfizer Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 003
        • Pfizer Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Pfizer Investigational Site
      • Kuala Lumpur, Malaysia, 50603
        • Pfizer Investigational Site
      • Kuala Lumpur, Malaysia, 55100
        • Pfizer Investigational Site
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Pfizer Investigational Site
  • Perù
      • Lima, Perù, L13
        • Pfizer Investigational Site
      • Lima, Perù, L41
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 229899
        • Pfizer Investigational Site
      • Singapore, Singapore, 539747
        • Pfizer Investigational Site
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35205
        • Pfizer Investigational Site
      • Birmingham, Alabama, Stati Uniti, 35294
        • Pfizer Investigational Site
      • Birmingham, Alabama, Stati Uniti, 35294-4400
        • Pfizer Investigational Site
    • California
      • San Diego, California, Stati Uniti, 92123
        • Pfizer Investigational Site
      • Stanford, California, Stati Uniti, 94305
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20010
        • Pfizer Investigational Site
    • Florida
      • Altamonte Springs, Florida, Stati Uniti, 32701
        • Pfizer Investigational Site
      • Fort Lauderdale, Florida, Stati Uniti, 33301
        • Pfizer Investigational Site
      • North Miami, Florida, Stati Uniti, 33161
        • Pfizer Investigational Site
      • Orange City, Florida, Stati Uniti, 32763
        • Pfizer Investigational Site
      • Tampa, Florida, Stati Uniti, 33613
        • Pfizer Investigational Site
      • Tavares, Florida, Stati Uniti, 32778
        • Pfizer Investigational Site
    • Georgia
      • Smyrna, Georgia, Stati Uniti, 30080
        • Pfizer Investigational Site
      • Tucker, Georgia, Stati Uniti, 30084
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Pfizer Investigational Site
    • Illinois
      • Des Plaines, Illinois, Stati Uniti, 60016
        • Pfizer Investigational Site
      • Oakbrook Terrace, Illinois, Stati Uniti, 60181
        • Pfizer Investigational Site
      • Schaumburg, Illinois, Stati Uniti, 60194
        • Pfizer Investigational Site
    • Maryland
      • Pikesville, Maryland, Stati Uniti, 21208
        • Pfizer Investigational Site
      • Towson, Maryland, Stati Uniti, 21204
        • Pfizer Investigational Site
      • Towson, Maryland, Stati Uniti, 21286
        • Pfizer Investigational Site
    • Michigan
      • Clinton Township, Michigan, Stati Uniti, 48038
        • Pfizer Investigational Site
    • Mississippi
      • Meridian, Mississippi, Stati Uniti, 39301
        • Pfizer Investigational Site
    • Missouri
      • Bridgeton, Missouri, Stati Uniti, 63044-2588
        • Pfizer Investigational Site
      • Saint Louis, Missouri, Stati Uniti, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, Stati Uniti, 68510
        • Pfizer Investigational Site
      • Omaha, Nebraska, Stati Uniti, 68131
        • Pfizer Investigational Site
    • New York
      • Buffalo, New York, Stati Uniti, 14215
        • Pfizer Investigational Site
      • Buffalo, New York, Stati Uniti, 14209
        • Pfizer Investigational Site
      • Rochester, New York, Stati Uniti, 14618
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, Stati Uniti, 45229
        • Pfizer Investigational Site
      • Cincinnati, Ohio, Stati Uniti, 45224
        • Pfizer Investigational Site
      • Cleveland, Ohio, Stati Uniti, 44106
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73101
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, Stati Uniti, 73116
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, Stati Uniti, 73107
        • Pfizer Investigational Site
    • Texas
      • Arlington, Texas, Stati Uniti, 76011
        • Pfizer Investigational Site
      • DeSoto, Texas, Stati Uniti, 75115
        • Pfizer Investigational Site
      • Plano, Texas, Stati Uniti, 75093
        • Pfizer Investigational Site
    • Washington
      • Bothell, Washington, Stati Uniti, 98011
        • Pfizer Investigational Site
      • Spokane, Washington, Stati Uniti, 99204
        • Pfizer Investigational Site
      • Spokane, Washington, Stati Uniti, 99216
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Pfizer Investigational Site
      • West Allis, Wisconsin, Stati Uniti, 53227
        • Pfizer Investigational Site
  • Ucraina
      • Dnipropetrovsk, Ucraina, 49005
        • Pfizer Investigational Site
      • Dnipropetrovsk, Ucraina, 49115
        • Pfizer Investigational Site
      • Donetsk, Ucraina, 83037
        • Pfizer Investigational Site
      • Kharkiv, Ucraina, 61068
        • Pfizer Investigational Site
      • Kyiv, Ucraina, 04655
        • Pfizer Investigational Site
      • Lugansk, Ucraina, 91045
        • Pfizer Investigational Site
      • Lviv, Ucraina, 79021
        • Pfizer Investigational Site
      • Odessa, Ucraina, 65006
        • Pfizer Investigational Site
      • Poltava, Ucraina, 36006
        • Pfizer Investigational Site
      • Vinnytsya, Ucraina, 21005
        • Pfizer Investigational Site
    • Crimea
      • Simferopol, Crimea, Ucraina, 95006
        • Pfizer Investigational Site

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

Da 13 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia: Current symptoms were to be present for at least 7 days before screening.
  • At the Screening and Baseline visits, subjects must have had a Brief Psychiatric Rating Scale - Anchored score ≥35 and a score of ≥4 on at least 1 of the following items: unusual thought content (i.e., delusions), hallucinations, suspiciousness, or conceptual disorganization.
  • Age 13 - 17 years

Exclusion Criteria:

  • Imminent risk of suicide or homicide, as judged by the site investigator
  • Any history of serious or unstable medical illness, including risk for QT prolongation

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: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: 2.0
Droga: placebo
Placebo matching the oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
Comparatore attivo: 1.0
Droga: Ziprasidone oral capsules
Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg BID to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
Altri nomi:
  • Geodonte, Zeldox

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6
Lasso di tempo: Baseline, Week 6
BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.
Baseline, Week 6

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6
Lasso di tempo: Baseline, Week 6
CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected.
Baseline, Week 6
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6
Lasso di tempo: Baseline, Week 6
PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.
Baseline, Week 6
Change From Baseline in PANSS: Positive and Negative Subscales at Week 6
Lasso di tempo: Baseline, Week 6
PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.
Baseline, Week 6
Clinical Global Impression of Improvement (CGI-I) Score at Week 6
Lasso di tempo: Baseline, Week 6
CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.
Baseline, Week 6
Change From Baseline in Children's Global Assessment Scale (CGAS)
Lasso di tempo: Baseline, Week 2, Week 4, Week 6, Early termination (ET)
CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.
Baseline, Week 2, Week 4, Week 6, Early termination (ET)
Change From Baseline in Child Health Questionnaire (CHQ)
Lasso di tempo: Baseline, Week 6, ET
CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.
Baseline, Week 6, ET
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
Lasso di tempo: Baseline, Week 1 through Week 6
CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.
Baseline, Week 1 through Week 6
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Lasso di tempo: Baseline, Week 1 through Week 6
CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.
Baseline, Week 1 through Week 6
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13
Lasso di tempo: Baseline, Week 1 through Week 6
CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).
Baseline, Week 1 through Week 6
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1
Lasso di tempo: Baseline, Week 2, Week 6
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).
Baseline, Week 2, Week 6
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Lasso di tempo: Baseline, Week 6, ET
A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
Baseline, Week 6, ET
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
Lasso di tempo: Baseline, Week 6, ET
A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
Baseline, Week 6, ET
Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)
Lasso di tempo: Baseline, Week 1 through Week 6
SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.
Baseline, Week 1 through Week 6
Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Lasso di tempo: Baseline, Week 1 through Week 6
BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.
Baseline, Week 1 through Week 6
Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Lasso di tempo: Baseline, Week 1 through Week 6
AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.
Baseline, Week 1 through Week 6
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Lasso di tempo: Baseline, Week 2, Week 6, ET
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Baseline, Week 2, Week 6, ET
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Lasso di tempo: Baseline, Week 2, Week 6, ET
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Baseline, Week 2, Week 6, ET
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Lasso di tempo: Baseline, Week 2, Week 6, ET
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Baseline, Week 2, Week 6, ET

Collaboratori e investigatori

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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

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 aprile 2006

Completamento primario (Effettivo)

1 marzo 2009

Completamento dello studio (Effettivo)

1 marzo 2009

Date di iscrizione allo studio

Primo inviato

21 novembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

21 novembre 2005

Primo Inserito (Stima)

22 novembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 marzo 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A1281134

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 .

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