ID

13132

Descrição

A Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT02435836

Link

https://clinicaltrials.gov/show/NCT02435836

Palavras-chave

  1. 19/01/2016 19/01/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

19 de janeiro de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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Eligibility Schizophrenia NCT02435836

Eligibility Schizophrenia NCT02435836

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. complete a prior study: each patient must meet one of the following conditions for completion of the prior study: a patient who has completed 52 weeks of post-randomization treatment in the prior double blind study (31-97-301 or 31-98-304-01) is eligible, with no further qualifications. a patient who was early-terminated from the study 31-97-301 or 31-98- 304-01 for either of the following two reasons is eligible to enter this open label study with no minimal required duration of prior double-blind participation: early termination was due to a marked deterioration of clinical status and no serious adverse events (sae) other than hospitalization has occurred. the marked clinical deterioration must be documented by at least a one-point increase in cgi-severity score from the baseline and a score of 6 (much worse) or 7 (very much worse) in cgi-global improvement at the time of termination, or early termination was due to a non-serious ae requiring discontinuation of the study drug a patient who was early terminated after a minimum of 4 weeks' participation in the double-blind treatment in study 31-97-301 or 31-98- 304-01 and the reason for early termination was withdrawal of consent due to lack of effect but not marked deterioration. this must be documented by no change from baseline in the cgi-severity score and a score of 4 (no change) or 5 (minimally worse) on the cgi-global improvement scale.
Descrição

participation in the prior study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
2. signing of informed consent form: prior to any procedure or drug administration, each patient must sign an informed consent form. in addition, if required by the ethical committee, each patient's next-of-kin or responsible caregiver will co-sign the patient's consent form or a separate consent form.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients suffering from any significant somatic disease or medical problem that would obscure the results of treatment, or that might require frequent changes of concomitant medication.
Descrição

any significant somatic disease or medical problem that would obscure the results of treatment, or that might require frequent changes of concomitant medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348563
2. patients with any acute or unstable medical condition requiring pharmacotherapy, other than schizophrenia.
Descrição

any acute or unstable medical condition requiring pharmacotherapy, other than schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
3. patients with an abnormal laboratory test value in the most recent analysis (from the study 31-97-301 or 31-98-304-01) which is considered by the investigator as presenting a significant risk to the patient for continuing treatment with aripiprazole.
Descrição

abnormal laboratory test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022877
4. patients who were early-terminated from the prior double-blind studies (31-97-301 or 31-98-304-01) due to a serious adverse event (sae) other than worsening of psychosis or hospitalization.
Descrição

early-terminated from the prior double-blind studies

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0877248
5. female patients of child bearing potential with a positive serum pregnancy test at the baseline (last visit of prior study) of this open-label follow-on study.
Descrição

pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
6. patients who have positive result in the urine screen for drugs of abuse (except for cannabis or medically-prescribed analgesics or benzodiazepines.)
Descrição

positive result in the urine screen for drugs of abuse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586

Similar models

Eligibility Schizophrenia NCT02435836

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
participation in the prior study
Item
1. complete a prior study: each patient must meet one of the following conditions for completion of the prior study: a patient who has completed 52 weeks of post-randomization treatment in the prior double blind study (31-97-301 or 31-98-304-01) is eligible, with no further qualifications. a patient who was early-terminated from the study 31-97-301 or 31-98- 304-01 for either of the following two reasons is eligible to enter this open label study with no minimal required duration of prior double-blind participation: early termination was due to a marked deterioration of clinical status and no serious adverse events (sae) other than hospitalization has occurred. the marked clinical deterioration must be documented by at least a one-point increase in cgi-severity score from the baseline and a score of 6 (much worse) or 7 (very much worse) in cgi-global improvement at the time of termination, or early termination was due to a non-serious ae requiring discontinuation of the study drug a patient who was early terminated after a minimum of 4 weeks' participation in the double-blind treatment in study 31-97-301 or 31-98- 304-01 and the reason for early termination was withdrawal of consent due to lack of effect but not marked deterioration. this must be documented by no change from baseline in the cgi-severity score and a score of 4 (no change) or 5 (minimally worse) on the cgi-global improvement scale.
boolean
C2348568 (UMLS CUI [1])
informed consent
Item
2. signing of informed consent form: prior to any procedure or drug administration, each patient must sign an informed consent form. in addition, if required by the ethical committee, each patient's next-of-kin or responsible caregiver will co-sign the patient's consent form or a separate consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
any significant somatic disease or medical problem that would obscure the results of treatment, or that might require frequent changes of concomitant medication
Item
1. patients suffering from any significant somatic disease or medical problem that would obscure the results of treatment, or that might require frequent changes of concomitant medication.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
any acute or unstable medical condition requiring pharmacotherapy, other than schizophrenia
Item
2. patients with any acute or unstable medical condition requiring pharmacotherapy, other than schizophrenia.
boolean
C0009488 (UMLS CUI [1])
abnormal laboratory test
Item
3. patients with an abnormal laboratory test value in the most recent analysis (from the study 31-97-301 or 31-98-304-01) which is considered by the investigator as presenting a significant risk to the patient for continuing treatment with aripiprazole.
boolean
C0022877 (UMLS CUI [1])
early-terminated from the prior double-blind studies
Item
4. patients who were early-terminated from the prior double-blind studies (31-97-301 or 31-98-304-01) due to a serious adverse event (sae) other than worsening of psychosis or hospitalization.
boolean
C0877248 (UMLS CUI [1])
pregnancy
Item
5. female patients of child bearing potential with a positive serum pregnancy test at the baseline (last visit of prior study) of this open-label follow-on study.
boolean
C0032961 (UMLS CUI [1])
positive result in the urine screen for drugs of abuse
Item
6. patients who have positive result in the urine screen for drugs of abuse (except for cannabis or medically-prescribed analgesics or benzodiazepines.)
boolean
C0038586 (UMLS CUI [1])

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