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Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

2 de marzo de 2021 actualizado por: 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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

284

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • Pfizer Investigational Site
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35205
        • Pfizer Investigational Site
      • Birmingham, Alabama, Estados Unidos, 35294
        • Pfizer Investigational Site
      • Birmingham, Alabama, Estados Unidos, 35294-4400
        • Pfizer Investigational Site
    • California
      • San Diego, California, Estados Unidos, 92123
        • Pfizer Investigational Site
      • Stanford, California, Estados Unidos, 94305
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20010
        • Pfizer Investigational Site
    • Florida
      • Altamonte Springs, Florida, Estados Unidos, 32701
        • Pfizer Investigational Site
      • Fort Lauderdale, Florida, Estados Unidos, 33301
        • Pfizer Investigational Site
      • North Miami, Florida, Estados Unidos, 33161
        • Pfizer Investigational Site
      • Orange City, Florida, Estados Unidos, 32763
        • Pfizer Investigational Site
      • Tampa, Florida, Estados Unidos, 33613
        • Pfizer Investigational Site
      • Tavares, Florida, Estados Unidos, 32778
        • Pfizer Investigational Site
    • Georgia
      • Smyrna, Georgia, Estados Unidos, 30080
        • Pfizer Investigational Site
      • Tucker, Georgia, Estados Unidos, 30084
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Pfizer Investigational Site
    • Illinois
      • Des Plaines, Illinois, Estados Unidos, 60016
        • Pfizer Investigational Site
      • Oakbrook Terrace, Illinois, Estados Unidos, 60181
        • Pfizer Investigational Site
      • Schaumburg, Illinois, Estados Unidos, 60194
        • Pfizer Investigational Site
    • Maryland
      • Pikesville, Maryland, Estados Unidos, 21208
        • Pfizer Investigational Site
      • Towson, Maryland, Estados Unidos, 21204
        • Pfizer Investigational Site
      • Towson, Maryland, Estados Unidos, 21286
        • Pfizer Investigational Site
    • Michigan
      • Clinton Township, Michigan, Estados Unidos, 48038
        • Pfizer Investigational Site
    • Mississippi
      • Meridian, Mississippi, Estados Unidos, 39301
        • Pfizer Investigational Site
    • Missouri
      • Bridgeton, Missouri, Estados Unidos, 63044-2588
        • Pfizer Investigational Site
      • Saint Louis, Missouri, Estados Unidos, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68510
        • Pfizer Investigational Site
      • Omaha, Nebraska, Estados Unidos, 68131
        • Pfizer Investigational Site
    • New York
      • Buffalo, New York, Estados Unidos, 14215
        • Pfizer Investigational Site
      • Buffalo, New York, Estados Unidos, 14209
        • Pfizer Investigational Site
      • Rochester, New York, Estados Unidos, 14618
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Pfizer Investigational Site
      • Cincinnati, Ohio, Estados Unidos, 45224
        • Pfizer Investigational Site
      • Cleveland, Ohio, Estados Unidos, 44106
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73101
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, Estados Unidos, 73116
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, Estados Unidos, 73107
        • Pfizer Investigational Site
    • Texas
      • Arlington, Texas, Estados Unidos, 76011
        • Pfizer Investigational Site
      • DeSoto, Texas, Estados Unidos, 75115
        • Pfizer Investigational Site
      • Plano, Texas, Estados Unidos, 75093
        • Pfizer Investigational Site
    • Washington
      • Bothell, Washington, Estados Unidos, 98011
        • Pfizer Investigational Site
      • Spokane, Washington, Estados Unidos, 99204
        • Pfizer Investigational Site
      • Spokane, Washington, Estados Unidos, 99216
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Pfizer Investigational Site
      • West Allis, Wisconsin, Estados Unidos, 53227
        • Pfizer Investigational Site
  • Federación Rusa
      • Kazan, Federación Rusa, 420012
        • Pfizer Investigational Site
      • Khotkovo, Moscow Region, Federación Rusa, 142601
        • Pfizer Investigational Site
      • Lipetsk Region, Federación Rusa, 399313
        • Pfizer Investigational Site
      • Moscow, Federación Rusa, 115522
        • Pfizer Investigational Site
      • Moscow, Federación Rusa, 107076
        • Pfizer Investigational Site
      • Moscow, Federación Rusa, 117152
        • Pfizer Investigational Site
      • Moscow, Federación Rusa, 127473
        • Pfizer Investigational Site
      • Moscow, Federación Rusa, 143300
        • Pfizer Investigational Site
      • Nizhniy Novgorod, Federación Rusa, 603155
        • Pfizer Investigational Site
      • Saratov, Federación Rusa, 410012
        • Pfizer Investigational Site
      • Saratov, Federación Rusa, 410060
        • Pfizer Investigational Site
      • St. Petersburg, Federación Rusa, 192019
        • Pfizer Investigational Site
      • Tver, Federación Rusa, 170005
        • Pfizer Investigational Site
      • Yaroslavl, Federación Rusa, 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
  • Malasia
      • Kuala Lumpur, Malasia, 50586
        • Pfizer Investigational Site
      • Kuala Lumpur, Malasia, 50603
        • Pfizer Investigational Site
      • Kuala Lumpur, Malasia, 55100
        • Pfizer Investigational Site
    • Kelantan
      • Kubang Kerian, Kelantan, Malasia, 16150
        • Pfizer Investigational Site
  • Perú
      • Lima, Perú, L13
        • Pfizer Investigational Site
      • Lima, Perú, L41
        • Pfizer Investigational Site
  • Singapur
      • Singapore, Singapur, 229899
        • Pfizer Investigational Site
      • Singapore, Singapur, 539747
        • Pfizer Investigational Site
  • Ucrania
      • Dnipropetrovsk, Ucrania, 49005
        • Pfizer Investigational Site
      • Dnipropetrovsk, Ucrania, 49115
        • Pfizer Investigational Site
      • Donetsk, Ucrania, 83037
        • Pfizer Investigational Site
      • Kharkiv, Ucrania, 61068
        • Pfizer Investigational Site
      • Kyiv, Ucrania, 04655
        • Pfizer Investigational Site
      • Lugansk, Ucrania, 91045
        • Pfizer Investigational Site
      • Lviv, Ucrania, 79021
        • Pfizer Investigational Site
      • Odessa, Ucrania, 65006
        • Pfizer Investigational Site
      • Poltava, Ucrania, 36006
        • Pfizer Investigational Site
      • Vinnytsya, Ucrania, 21005
        • Pfizer Investigational Site
    • Crimea
      • Simferopol, Crimea, Ucrania, 95006
        • Pfizer Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

13 años a 17 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: 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.
Comparador activo: 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.
Otros nombres:
  • Geodón, Zeldox

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2006

Finalización primaria (Actual)

1 de marzo de 2009

Finalización del estudio (Actual)

1 de marzo de 2009

Fechas de registro del estudio

Enviado por primera vez

21 de noviembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

21 de noviembre de 2005

Publicado por primera vez (Estimar)

22 de noviembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de marzo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

2 de marzo de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A1281134

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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