ID

28039

Descrizione

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Screening/Enrollment

Keywords

versioni (6)
  1. 25/08/17 25/08/17 -
  2. 25/08/17 25/08/17 -
  3. 25/08/17 25/08/17 -
  4. 13/10/17 13/10/17 -
  5. 23/10/17 23/10/17 -
  6. 12/12/17 12/12/17 -
Titolare del copyright

GlaxoSmithKline

Caricato su

12 dicembre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Screening/Enrollment GSK study Chronic Coronary Heart Disease NCT00799903

Inglese

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 moduli  
Screening
Descrizione

Screening

1. Subject initials
Descrizione

This item is hidden to all users and will be autopopulated by the system as "---"

Tipo di dati

text

Alias
UMLS CUI [1]
C2986440
2. Date of birth
Descrizione

Will be automatically mapped to demography form

Tipo di dati

date

Alias
UMLS CUI [1]
C0421451
3. eGFR value used for screening
Descrizione

eGFR

Tipo di dati

integer

Alias
UMLS CUI [1]
C3811844
4. Was this subject a screen failure?
Descrizione

If Yes, check all that apply. If you are not collecting data on screen failures then the Screen Failure question cannot be removed from the SCREEN form, although the list of reasons can be edited. Subject Number is optional. If not needed, remove control and from the group control.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1710476
Reason for screen failure
Descrizione

Reason for screen failure

[F01] Did not meet inclusion/exclusion criteria
Descrizione

Inclusion exclusion criteria

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
[F10] Subject withdrew consent prior to randomisation
Descrizione

Withdrawal of consent

Tipo di dati

boolean

[F06] Study closed/terminated prior to randomisation
Descrizione

Study closed/ terminated

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348570
[F07] Lost to follow up prior to randomisation
Descrizione

Lost to follow up

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1302313
If subject did not meet inclusion/exclusion criteria, specify:
Descrizione

If subject did not meet inclusion/exclusion criteria, specify:

[I02] Inclusion Criteria 2: Male or female at least 18 years old at screening and females postmenopausal or using highly effective method to avoid pregnancy
Descrizione

Inclusion Criteria sex pregnancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
[I03] Inclusion Criteria 3: Current treatment with statin therapy unless contraindicated
Descrizione

Inclusion Criteria statin therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0360714
[I04] Inclusion Criteria 4: Chronic CHD documented
Descrizione

Inclusion Criteria Chronic CHD

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0010068
[I05] Inclusion Criteria 5: At least one additional predictor of CV risk
Descrizione

Inclusion Criteria additional predictors of CV risk

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0850624
[E01] Exclusion Criteria 1: Planned coronary revascularization (PCI or CABG) or any other major surgical procedure
Descrizione

Exclusion Criteria Planned coronary PCI or CABG

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0085532
UMLS CUI [1,2]
C0010055
UMLS CUI [1,3]
C1532338
[E02] Exclusion Criteria 2: Current liver disease, known hepatic or biliary abnormalities evidence of abnormal liver function tests
Descrizione

Exclusion Criteria abnormal liver function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0086565
[E03] Exclusion Criteria 3: Severe renal impairment or history of nephrectomy or kidney transplant
Descrizione

Exclusion Criteria renal impairment

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1565489
[E04] Exclusion Criteria 4: Current severe heart failure
Descrizione

Exclusion Criteria heart failure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018801
[E05] Exclusion Criteria 5: Poorly controlled hypertension despite lifestyle modifications and pharmacotherapy
Descrizione

Exclusion Criteria hypertension

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0020538
[E06] Exclusion Criteria 6: Any life-threatening condition with life expectancy less than 2 years
Descrizione

Exclusion Criteria life expectancy less than 2 years

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023671
[E07] Exclusion Criteria 7: Severe asthma that is poorly controlled on pharmacotherapy
Descrizione

Exclusion Criteria asthma

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0155877
[E08] Exclusion Criteria 8: Positive pregnancy test or is known to be pregnant or lactating
Descrizione

Exclusion Criteria pregnancy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0032961
[E09] Exclusion Criteria 9: History of anaphylaxis, anaphylactoid reactions severe allergic responses
Descrizione

Exclusion Criteria allergy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0020517
[E10] Exclusion Criteria 10: Alcohol or drug abuse within the past 6 months, or current mental condition which may affect study compliance
Descrizione

Exclusion Criteria Alcohol or drug abuse

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
[E11] Exclusion Criteria 11: Current or planned chronic administration of strong oral or injectable CYP3A4 inhibitors
Descrizione

Exclusion Criteria CYP3A4 inhibitors

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3830624
[E12] Exclusion Criteria 12: Subjects with both parents of Japanese, Chinese, or Korean ancestry with Lp-PLA2 activity less or eq 20 nmol/min/mL
Descrizione

Exclusion Criteria Lp-PLA2 activity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0031671
[E13] Exclusion Criteria 13: Previous exposure to darapladib (SB-480848)
Descrizione

Exclusion Criteria exposure to darapladib

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348075
[E14] Exclusion Criteria 14: Use of another investigational product within 30 days or 5 half-lives preceding the first dose of darapladib or matching placebo
Descrizione

Exclusion Criteria Use of other IP

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0304229
[E15] Exclusion Criteria 15: Currently in a study of an investigational device
Descrizione

Exclusion Criteria study of investigational device

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2346570
[E16] Exclusion Criteria 16: Any other reason the investigator deems the subject to be unsuitable for the study
Descrizione

Exclusion Criteria other

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205394
[E16] Exclusion Criteria 16, specify:
Descrizione

Exclusion Criteria other specification

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348235
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Similar models

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Screening
Subject initials
Item
1. Subject initials
text
C2986440 (UMLS CUI [1])
Date of birth
Item
2. Date of birth
date
C0421451 (UMLS CUI [1])
eGFR
Item
3. eGFR value used for screening
integer
C3811844 (UMLS CUI [1])
screen failure
Item
4. Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Item Group
Reason for screen failure
Inclusion exclusion criteria
Item
[F01] Did not meet inclusion/exclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Withdrawal of consent
Item
[F10] Subject withdrew consent prior to randomisation
boolean
Study closed/ terminated
Item
[F06] Study closed/terminated prior to randomisation
boolean
C2348570 (UMLS CUI [1])
Lost to follow up
Item
[F07] Lost to follow up prior to randomisation
boolean
C1302313 (UMLS CUI [1])
Item Group
If subject did not meet inclusion/exclusion criteria, specify:
Inclusion Criteria sex pregnancy
Item
[I02] Inclusion Criteria 2: Male or female at least 18 years old at screening and females postmenopausal or using highly effective method to avoid pregnancy
boolean
C0032961 (UMLS CUI [1])
Inclusion Criteria statin therapy
Item
[I03] Inclusion Criteria 3: Current treatment with statin therapy unless contraindicated
boolean
C0360714 (UMLS CUI [1])
Inclusion Criteria Chronic CHD
Item
[I04] Inclusion Criteria 4: Chronic CHD documented
boolean
C0010068 (UMLS CUI [1])
Inclusion Criteria additional predictors of CV risk
Item
[I05] Inclusion Criteria 5: At least one additional predictor of CV risk
boolean
C0850624 (UMLS CUI [1])
Exclusion Criteria Planned coronary PCI or CABG
Item
[E01] Exclusion Criteria 1: Planned coronary revascularization (PCI or CABG) or any other major surgical procedure
boolean
C0085532 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
Exclusion Criteria abnormal liver function
Item
[E02] Exclusion Criteria 2: Current liver disease, known hepatic or biliary abnormalities evidence of abnormal liver function tests
boolean
C0086565 (UMLS CUI [1])
Exclusion Criteria renal impairment
Item
[E03] Exclusion Criteria 3: Severe renal impairment or history of nephrectomy or kidney transplant
boolean
C1565489 (UMLS CUI [1])
Exclusion Criteria heart failure
Item
[E04] Exclusion Criteria 4: Current severe heart failure
boolean
C0018801 (UMLS CUI [1])
Exclusion Criteria hypertension
Item
[E05] Exclusion Criteria 5: Poorly controlled hypertension despite lifestyle modifications and pharmacotherapy
boolean
C0020538 (UMLS CUI [1])
Exclusion Criteria life expectancy less than 2 years
Item
[E06] Exclusion Criteria 6: Any life-threatening condition with life expectancy less than 2 years
boolean
C0023671 (UMLS CUI [1])
Exclusion Criteria asthma
Item
[E07] Exclusion Criteria 7: Severe asthma that is poorly controlled on pharmacotherapy
boolean
C0680251 (UMLS CUI [1,1])
C0155877 (UMLS CUI [1,2])
Exclusion Criteria pregnancy
Item
[E08] Exclusion Criteria 8: Positive pregnancy test or is known to be pregnant or lactating
boolean
C0680251 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
Exclusion Criteria allergy
Item
[E09] Exclusion Criteria 9: History of anaphylaxis, anaphylactoid reactions severe allergic responses
boolean
C0020517 (UMLS CUI [1])
Exclusion Criteria Alcohol or drug abuse
Item
[E10] Exclusion Criteria 10: Alcohol or drug abuse within the past 6 months, or current mental condition which may affect study compliance
boolean
C0038586 (UMLS CUI [1])
Exclusion Criteria CYP3A4 inhibitors
Item
[E11] Exclusion Criteria 11: Current or planned chronic administration of strong oral or injectable CYP3A4 inhibitors
boolean
C3830624 (UMLS CUI [1])
Exclusion Criteria Lp-PLA2 activity
Item
[E12] Exclusion Criteria 12: Subjects with both parents of Japanese, Chinese, or Korean ancestry with Lp-PLA2 activity less or eq 20 nmol/min/mL
boolean
C0031671 (UMLS CUI [1])
Exclusion Criteria exposure to darapladib
Item
[E13] Exclusion Criteria 13: Previous exposure to darapladib (SB-480848)
boolean
C2348075 (UMLS CUI [1])
Exclusion Criteria Use of other IP
Item
[E14] Exclusion Criteria 14: Use of another investigational product within 30 days or 5 half-lives preceding the first dose of darapladib or matching placebo
boolean
C0304229 (UMLS CUI [1])
Exclusion Criteria study of investigational device
Item
[E15] Exclusion Criteria 15: Currently in a study of an investigational device
boolean
C2346570 (UMLS CUI [1])
Exclusion Criteria other
Item
[E16] Exclusion Criteria 16: Any other reason the investigator deems the subject to be unsuitable for the study
boolean
C0680251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Exclusion Criteria other specification
Item
[E16] Exclusion Criteria 16, specify:
text
C0680251 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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