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Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

2 марта 2021 г. обновлено: 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

Обзор исследования

Статус

Прекращено

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

284

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 13 лет до 17 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: 2.0
Лекарство: 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.
Активный компаратор: 1.0
Лекарство: 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.
Другие имена:
  • Геодон, Зельдокс

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

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

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 апреля 2006 г.

Первичное завершение (Действительный)

1 марта 2009 г.

Завершение исследования (Действительный)

1 марта 2009 г.

Даты регистрации исследования

Первый отправленный

21 ноября 2005 г.

Впервые представлено, что соответствует критериям контроля качества

21 ноября 2005 г.

Первый опубликованный (Оценивать)

22 ноября 2005 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

25 марта 2021 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 марта 2021 г.

Последняя проверка

1 марта 2021 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • A1281134

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