ID

25152

Beschrijving

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

Trefwoorden

  1. 27-08-17 27-08-17 -
  2. 23-10-17 23-10-17 -
  3. 12-12-17 12-12-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

27 augustus 2017

DOI

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Licentie

Creative Commons BY-NC 3.0

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Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

Standard of care medications
Beschrijving

Standard of care medications

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

STATIN therapy prior to randomisation

Datatype

boolean

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

STATIN therapy at randomisation

Datatype

boolean

If no, indicate reason
Beschrijving

no STATIN therapy at randomisation reason

Datatype

text

If other reason, specify:
Beschrijving

no STATIN therapy at randomisation other reason

Datatype

text

3. Was the subject regularly taking ASPIRIN therapy for 8 weeks or more prior to randomisation?
Beschrijving

ASPIRIN therapy prior to randomisation

Datatype

boolean

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

ASPIRIN at randomisation

Datatype

boolean

If no, indicate reason:
Beschrijving

no ASPIRIN at randomisation reason

Datatype

text

If other reason, specify:
Beschrijving

no ASPIRIN at randomisation other reason

Datatype

text

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

P2Y12 inhibitors

Datatype

boolean

If no, indicate reason:
Beschrijving

no P2Y12 inhibitors reason

Datatype

text

If other reason, specify:
Beschrijving

no P2Y12 inhibitors other reason

Datatype

text

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

beta-blocker

Datatype

boolean

If no, indicate reason:
Beschrijving

no beta-blocker reason

Datatype

text

If other reason, specify:
Beschrijving

no beta-blocker other reason

Datatype

text

7. Is the subject taking an ACE inhibitor?
Beschrijving

ACE inhibitor

Datatype

boolean

If no, indicate reason:
Beschrijving

no ACE inhibitor reason

Datatype

text

If other reason, specify:
Beschrijving

no ACE inhibitors other reason

Datatype

text

8. Is the subject taking an ARB?
Beschrijving

ARB

Datatype

boolean

If no, indicate reason:
Beschrijving

no ARB reason

Datatype

text

If other reason, specify:
Beschrijving

no ARB other reason

Datatype

text

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

renin-angiotensin-aldosterone system-targeted medication

Datatype

boolean

If no, indicate reason:
Beschrijving

no renin-angiotensin-aldosterone system-targeted medication reason

Datatype

text

If other reason, specify:
Beschrijving

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

Datatype

text

Similar models

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
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
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
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
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
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
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
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
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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