ID

26242

Description

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

Versions (6)
  1. 8/25/17 8/25/17 -
  2. 8/25/17 8/25/17 -
  3. 8/25/17 8/25/17 -
  4. 10/13/17 10/13/17 -
  5. 10/23/17 10/23/17 -
  6. 12/12/17 12/12/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 13, 2017

DOI

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License

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

English

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 forms  
Screening
Description

Screening

1. Subject initials
Description

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

Data type

text

2. Date of birth
Description

Will be automatically mapped to demography form

Data type

date

3. eGFR value used for screening
Description

eGFR

Data type

integer

4. Was this subject a screen failure?
Description

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.

Data type

boolean

Reason for screen failure
Description

Reason for screen failure

[F01] Did not meet inclusion/exclusion criteria
Description

Inclusion exclusion criteria

Data type

boolean

[F10] Subject withdrew consent prior to randomisation
Description

Withdrawal of consent

Data type

boolean

[F06] Study closed/terminated prior to randomisation
Description

Study closed/terminated

Data type

boolean

[F07] Lost to follow up prior to randomisation
Description

Lost to follow up

Data type

boolean

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

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
Description

Inclusion Criteria sex pregnancy

Data type

boolean

[I03] Inclusion Criteria 3: Current treatment with statin therapy unless contraindicated
Description

Inclusion Criteria statin therapy

Data type

boolean

[I04] Inclusion Criteria 4: Chronic CHD documented
Description

Inclusion Criteria Chronic CHD

Data type

boolean

[I05] Inclusion Criteria 5: At least one additional predictor of CV risk
Description

Inclusion Criteria additional predictors of CV risk

Data type

boolean

[E01] Exclusion Criteria 1: Planned coronary revascularization (PCI or CABG) or any other major surgical procedure
Description

Exclusion Criteria Planned coronary PCI or CABG

Data type

boolean

[E02] Exclusion Criteria 2: Current liver disease, known hepatic or biliary abnormalities evidence of abnormal liver function tests
Description

Exclusion Criteria abnormal liver function

Data type

boolean

[E03] Exclusion Criteria 3: Severe renal impairment or history of nephrectomy or kidney transplant
Description

Exclusion Criteria renal impairment

Data type

boolean

[E04] Exclusion Criteria 4: Current severe heart failure
Description

Exclusion Criteria heart failure

Data type

boolean

[E05] Exclusion Criteria 5: Poorly controlled hypertension despite lifestyle modifications and pharmacotherapy
Description

Exclusion Criteria hypertension

Data type

boolean

[E06] Exclusion Criteria 6: Any life-threatening condition with life expectancy less than 2 years
Description

Exclusion Criteria life expectancy less than 2 years

Data type

boolean

[E07] Exclusion Criteria 7: Severe asthma that is poorly controlled on pharmacotherapy
Description

Exclusion Criteria asthma

Data type

boolean

[E08] Exclusion Criteria 8: Positive pregnancy test or is known to be pregnant or lactating
Description

Exclusion Criteria pregnancy

Data type

boolean

[E09] Exclusion Criteria 9: History of anaphylaxis, anaphylactoid reactions severe allergic responses
Description

Exclusion Criteria allergy

Data type

boolean

[E10] Exclusion Criteria 10: Alcohol or drug abuse within the past 6 months, or current mental condition which may affect study compliance
Description

Exclusion Criteria Alcohol or drug abuse

Data type

boolean

[E11] Exclusion Criteria 11: Current or planned chronic administration of strong oral or injectable CYP3A4 inhibitors
Description

Exclusion Criteria CYP3A4 inhibitors

Data type

boolean

[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
Description

Exclusion Criteria Lp-PLA2 activity

Data type

boolean

[E13] Exclusion Criteria 13: Previous exposure to darapladib (SB-480848)
Description

Exclusion Criteria exposure to darapladib

Data type

boolean

[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
Description

Exclusion Criteria Use of other IP

Data type

boolean

[E15] Exclusion Criteria 15: Currently in a study of an investigational device
Description

Exclusion Criteria study of investigational device

Data type

boolean

[E16] Exclusion Criteria 16: Any other reason the investigator deems the subject to be unsuitable for the study
Description

Exclusion Criteria other

Data type

boolean

[E16] Exclusion Criteria 16, specify:
Description

Exclusion Criteria other specification

Data type

text

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Similar models

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Screening
Subject initials
Item
1. Subject initials
text
Date of birth
Item
2. Date of birth
date
eGFR
Item
3. eGFR value used for screening
integer
screen failure
Item
4. Was this subject a screen failure?
boolean
Item Group
Reason for screen failure
Inclusion exclusion criteria
Item
[F01] Did not meet inclusion/exclusion criteria
boolean
Withdrawal of consent
Item
[F10] Subject withdrew consent prior to randomisation
boolean
Study closed/terminated
Item
[F06] Study closed/terminated prior to randomisation
boolean
Lost to follow up
Item
[F07] Lost to follow up prior to randomisation
boolean
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
Inclusion Criteria statin therapy
Item
[I03] Inclusion Criteria 3: Current treatment with statin therapy unless contraindicated
boolean
Inclusion Criteria Chronic CHD
Item
[I04] Inclusion Criteria 4: Chronic CHD documented
boolean
Inclusion Criteria additional predictors of CV risk
Item
[I05] Inclusion Criteria 5: At least one additional predictor of CV risk
boolean
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
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
Exclusion Criteria renal impairment
Item
[E03] Exclusion Criteria 3: Severe renal impairment or history of nephrectomy or kidney transplant
boolean
Exclusion Criteria heart failure
Item
[E04] Exclusion Criteria 4: Current severe heart failure
boolean
Exclusion Criteria hypertension
Item
[E05] Exclusion Criteria 5: Poorly controlled hypertension despite lifestyle modifications and pharmacotherapy
boolean
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
Exclusion Criteria asthma
Item
[E07] Exclusion Criteria 7: Severe asthma that is poorly controlled on pharmacotherapy
boolean
Exclusion Criteria pregnancy
Item
[E08] Exclusion Criteria 8: Positive pregnancy test or is known to be pregnant or lactating
boolean
Exclusion Criteria allergy
Item
[E09] Exclusion Criteria 9: History of anaphylaxis, anaphylactoid reactions severe allergic responses
boolean
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
Exclusion Criteria CYP3A4 inhibitors
Item
[E11] Exclusion Criteria 11: Current or planned chronic administration of strong oral or injectable CYP3A4 inhibitors
boolean
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
Exclusion Criteria exposure to darapladib
Item
[E13] Exclusion Criteria 13: Previous exposure to darapladib (SB-480848)
boolean
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
Exclusion Criteria study of investigational device
Item
[E15] Exclusion Criteria 15: Currently in a study of an investigational device
boolean
Exclusion Criteria other
Item
[E16] Exclusion Criteria 16: Any other reason the investigator deems the subject to be unsuitable for the study
boolean
Exclusion Criteria other specification
Item
[E16] Exclusion Criteria 16, specify:
text
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