ID

28039

Beskrivning

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

Nyckelord

Versioner (6)
  1. 2017-08-25 2017-08-25 -
  2. 2017-08-25 2017-08-25 -
  3. 2017-08-25 2017-08-25 -
  4. 2017-10-13 2017-10-13 -
  5. 2017-10-23 2017-10-23 -
  6. 2017-12-12 2017-12-12 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

12 december 2017

DOI

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Licens

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

Engelsk

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 Formulär  
Screening
Beskrivning

Screening

1. Subject initials
Beskrivning

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

Datatyp

text

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

Will be automatically mapped to demography form

Datatyp

date

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

eGFR

Datatyp

integer

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

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.

Datatyp

boolean

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

Reason for screen failure

[F01] Did not meet inclusion/exclusion criteria
Beskrivning

Inclusion exclusion criteria

Datatyp

boolean

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

Withdrawal of consent

Datatyp

boolean

[F06] Study closed/terminated prior to randomisation
Beskrivning

Study closed/ terminated

Datatyp

boolean

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

Lost to follow up

Datatyp

boolean

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

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
Beskrivning

Inclusion Criteria sex pregnancy

Datatyp

boolean

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

Inclusion Criteria statin therapy

Datatyp

boolean

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

Inclusion Criteria Chronic CHD

Datatyp

boolean

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

Inclusion Criteria additional predictors of CV risk

Datatyp

boolean

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

Exclusion Criteria Planned coronary PCI or CABG

Datatyp

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
Beskrivning

Exclusion Criteria abnormal liver function

Datatyp

boolean

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

Exclusion Criteria renal impairment

Datatyp

boolean

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

Exclusion Criteria heart failure

Datatyp

boolean

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

Exclusion Criteria hypertension

Datatyp

boolean

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

Exclusion Criteria life expectancy less than 2 years

Datatyp

boolean

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

Exclusion Criteria asthma

Datatyp

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
Beskrivning

Exclusion Criteria pregnancy

Datatyp

boolean

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

Exclusion Criteria allergy

Datatyp

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
Beskrivning

Exclusion Criteria Alcohol or drug abuse

Datatyp

boolean

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

Exclusion Criteria CYP3A4 inhibitors

Datatyp

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
Beskrivning

Exclusion Criteria Lp-PLA2 activity

Datatyp

boolean

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

Exclusion Criteria exposure to darapladib

Datatyp

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
Beskrivning

Exclusion Criteria Use of other IP

Datatyp

boolean

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

Exclusion Criteria study of investigational device

Datatyp

boolean

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

Exclusion Criteria other

Datatyp

boolean

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

Exclusion Criteria other specification

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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