ID

26682

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

October 23, 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

2. Was the subject taking STATIN therapy at the time of randomisation?
Description

STATIN therapy at randomisation

Data type

boolean

If no, indicate reason
Description

no STATIN therapy at randomisation reason

Data type

text

If other reason, specify:
Description

no STATIN therapy at randomisation other reason

Data type

text

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

4. Was the subject taking ASPIRIN at the time of randomisation?
Description

ASPIRIN at randomisation

Data type

boolean

If no, indicate reason:
Description

no ASPIRIN at randomisation reason

Data type

text

If other reason, specify:
Description

no ASPIRIN at randomisation other reason

Data type

text

5. Is the subject regularly taking any P2Y12 inhibitors (i.e. thienopyridines)?
Description

P2Y12 inhibitors

Data type

boolean

If no, indicate reason:
Description

no P2Y12 inhibitors reason

Data type

text

If other reason, specify:
Description

no P2Y12 inhibitors other reason

Data type

text

6. Is the subject taking a beta-blocker?
Description

beta-blocker

Data type

boolean

If no, indicate reason:
Description

no beta-blocker reason

Data type

text

If other reason, specify:
Description

no beta-blocker other reason

Data type

text

7. Is the subject taking an ACE inhibitor?
Description

ACE inhibitor

Data type

boolean

If no, indicate reason:
Description

no ACE inhibitor reason

Data type

text

If other reason, specify:
Description

no ACE inhibitors other reason

Data type

text

8. Is the subject taking an ARB?
Description

ARB

Data type

boolean

If no, indicate reason:
Description

no ARB reason

Data type

text

If other reason, specify:
Description

no ARB other reason

Data type

text

9. Is the subject taking any other renin-angiotensin-aldosterone system-targeted medication?
Description

renin-angiotensin-aldosterone system-targeted medication

Data type

boolean

If no, indicate reason:
Description

no renin-angiotensin-aldosterone system-targeted medication reason

Data type

text

If other reason, specify:
Description

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

Data type

text

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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
STATIN therapy at randomisation
Item
2. Was the subject taking STATIN therapy at the time of randomisation?
boolean
Item
If no, indicate reason
text
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)
Item
If other reason, specify:
text
no STATIN therapy at randomisation reason
Code List
If other reason, specify:
ASPIRIN therapy prior to randomisation
Item
3. Was the subject regularly taking ASPIRIN therapy for 8 weeks or more prior to randomisation?
boolean
ASPIRIN at randomisation
Item
4. Was the subject taking ASPIRIN at the time of randomisation?
boolean
Item
If no, indicate reason:
text
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:
text
P2Y12 inhibitors
Item
5. Is the subject regularly taking any P2Y12 inhibitors (i.e. thienopyridines)?
boolean
Item
If no, indicate reason:
text
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
beta-blocker
Item
6. Is the subject taking a beta-blocker?
boolean
Item
If no, indicate reason:
text
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
ACE inhibitor
Item
7. Is the subject taking an ACE inhibitor?
boolean
Item
If no, indicate reason:
text
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
ARB
Item
8. Is the subject taking an ARB?
boolean
Item
If no, indicate reason:
text
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
renin-angiotensin-aldosterone system-targeted medication
Item
9. Is the subject taking any other renin-angiotensin-aldosterone system-targeted medication?
boolean
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
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