ID

28050

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: Standard of care medications

Keywords

Versions (3)
  1. 8/27/17 8/27/17 -
  2. 10/23/17 10/23/17 -
  3. 12/12/17 12/12/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 12, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

English

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Standard of care medications
Description

Standard of care medications

1. Was the subject regularly taking STATIN therapy for 8 weeks or more prior to randomisation?
Description

STATIN therapy prior to randomisation

Data type

boolean

Alias
UMLS CUI [1]
C0360714
2. Was the subject taking STATIN therapy at the time of randomisation?
Description

STATIN therapy at randomisation

Data type

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C0034656
If no, indicate reason
Description

no STATIN therapy at randomisation reason

Data type

text

Alias
UMLS CUI [1]
C0360714
If other reason, specify:
Description

no STATIN therapy at randomisation other reason

Data type

text

Alias
UMLS CUI [1,1]
C0746919
UMLS CUI [1,2]
C3840932
3. Was the subject regularly taking ASPIRIN therapy for 8 weeks or more prior to randomisation?
Description

ASPIRIN therapy prior to randomisation

Data type

boolean

Alias
UMLS CUI [1]
C4303556
4. Was the subject taking ASPIRIN at the time of randomisation?
Description

ASPIRIN at randomisation

Data type

boolean

Alias
UMLS CUI [1]
C0004057
If no, indicate reason:
Description

no ASPIRIN at randomisation reason

Data type

text

Alias
UMLS CUI [1]
C0004057
If other reason, specify:
Description

no ASPIRIN at randomisation other reason

Data type

integer

Alias
UMLS CUI [1,1]
C0746919
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C0004057
5. Is the subject regularly taking any P2Y12 inhibitors (i.e. thienopyridines)?
Description

P2Y12 inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C2936585
If no, indicate reason:
Description

no P2Y12 inhibitors reason

Data type

text

Alias
UMLS CUI [1]
C2936585
If other reason, specify:
Description

no P2Y12 inhibitors other reason

Data type

text

Alias
UMLS CUI [1]
C2936585
6. Is the subject taking a beta-blocker?
Description

beta-blocker

Data type

boolean

Alias
UMLS CUI [1]
C0001645
If no, indicate reason:
Description

no beta-blocker reason

Data type

text

Alias
UMLS CUI [1]
C0001645
If other reason, specify:
Description

no beta-blocker other reason

Data type

text

Alias
UMLS CUI [1]
C0001645
7. Is the subject taking an ACE inhibitor?
Description

ACE inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0003015
If no, indicate reason:
Description

no ACE inhibitor reason

Data type

text

Alias
UMLS CUI [1]
C0003015
If other reason, specify:
Description

no ACE inhibitors other reason

Data type

text

Alias
UMLS CUI [1]
C0003015
8. Is the subject taking an ARB?
Description

ARB

Data type

boolean

Alias
UMLS CUI [1]
C0521942
If no, indicate reason:
Description

no ARB reason

Data type

text

Alias
UMLS CUI [1]
C0521942
If other reason, specify:
Description

no ARB other reason

Data type

text

Alias
UMLS CUI [1,1]
C0746919
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C0521942
9. Is the subject taking any other renin-angiotensin-aldosterone system-targeted medication?
Description

renin-angiotensin-aldosterone system-targeted medication

Data type

boolean

Alias
UMLS CUI [1]
C3653735
If no, indicate reason:
Description

no renin-angiotensin-aldosterone system-targeted medication reason

Data type

text

Alias
UMLS CUI [1]
C3653735
If other reason, specify:
Description

no renin-angiotensin-aldosterone system-targeted medication other reason

Data type

text

Alias
UMLS CUI [1]
C3653735
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Similar models

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Standard of care medications
STATIN therapy prior to randomisation
Item
1. Was the subject regularly taking STATIN therapy for 8 weeks or more prior to randomisation?
boolean
C0360714 (UMLS CUI [1])
STATIN therapy at randomisation
Item
2. Was the subject taking STATIN therapy at the time of randomisation?
boolean
C0360714 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item
If no, indicate reason
text
C0360714 (UMLS CUI [1])
no STATIN therapy at randomisation reason
Code List
If no, indicate reason
CL Item
Subject is intolerant or clinically contraindicated (1)
CL Item
Other (OT)
no STATIN therapy at randomisation other reason
Item
If other reason, specify:
text
C0746919 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
ASPIRIN therapy prior to randomisation
Item
3. Was the subject regularly taking ASPIRIN therapy for 8 weeks or more prior to randomisation?
boolean
C4303556 (UMLS CUI [1])
ASPIRIN at randomisation
Item
4. Was the subject taking ASPIRIN at the time of randomisation?
boolean
C0004057 (UMLS CUI [1])
Item
If no, indicate reason:
text
C0004057 (UMLS CUI [1])
no STATIN therapy at randomisation reason
Code List
If no, indicate reason:
CL Item
Subject is intolerant or clinically contraindicated (1)
CL Item
Other (OT)
no ASPIRIN at randomisation other reason
Item
If other reason, specify:
integer
C0746919 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
P2Y12 inhibitors
Item
5. Is the subject regularly taking any P2Y12 inhibitors (i.e. thienopyridines)?
boolean
C2936585 (UMLS CUI [1])
Item
If no, indicate reason:
text
C2936585 (UMLS CUI [1])
no STATIN therapy at randomisation reason
Code List
If no, indicate reason:
CL Item
Subject is intolerant or clinically contraindicated (1)
CL Item
Other (OT)
CL Item
Not clinically indicated (2)
no P2Y12 inhibitors other reason
Item
If other reason, specify:
text
C2936585 (UMLS CUI [1])
beta-blocker
Item
6. Is the subject taking a beta-blocker?
boolean
C0001645 (UMLS CUI [1])
Item
If no, indicate reason:
text
C0001645 (UMLS CUI [1])
no STATIN therapy at randomisation reason
Code List
If no, indicate reason:
CL Item
Subject is intolerant or clinically contraindicated (1)
CL Item
Other (OT)
CL Item
Not clinically indicated (2)
no beta-blocker other reason
Item
If other reason, specify:
text
C0001645 (UMLS CUI [1])
ACE inhibitor
Item
7. Is the subject taking an ACE inhibitor?
boolean
C0003015 (UMLS CUI [1])
Item
If no, indicate reason:
text
C0003015 (UMLS CUI [1])
no STATIN therapy at randomisation reason
Code List
If no, indicate reason:
CL Item
Subject is intolerant or clinically contraindicated (1)
CL Item
Other (OT)
CL Item
Not clinically indicated (2)
no ACE inhibitors other reason
Item
If other reason, specify:
text
C0003015 (UMLS CUI [1])
ARB
Item
8. Is the subject taking an ARB?
boolean
C0521942 (UMLS CUI [1])
Item
If no, indicate reason:
text
C0521942 (UMLS CUI [1])
no STATIN therapy at randomisation reason
Code List
If no, indicate reason:
CL Item
Subject is intolerant or clinically contraindicated (1)
CL Item
Other (OT)
CL Item
Not clinically indicated (2)
no ARB other reason
Item
If other reason, specify:
text
C0746919 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C0521942 (UMLS CUI [1,3])
renin-angiotensin-aldosterone system-targeted medication
Item
9. Is the subject taking any other renin-angiotensin-aldosterone system-targeted medication?
boolean
C3653735 (UMLS CUI [1])
Item
If no, indicate reason:
text
C3653735 (UMLS CUI [1])
no STATIN therapy at randomisation reason
Code List
If no, indicate reason:
CL Item
Subject is intolerant or clinically contraindicated (1)
CL Item
Other (OT)
CL Item
Not clinically indicated (2)
no renin-angiotensin-aldosterone system-targeted medication other reason
Item
If other reason, specify:
text
C3653735 (UMLS CUI [1])
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