ID

25152

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: Standard of care medications

Nyckelord

Versioner (3)
  1. 2017-08-27 2017-08-27 -
  2. 2017-10-23 2017-10-23 -
  3. 2017-12-12 2017-12-12 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

27 augusti 2017

DOI

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Licens

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

Engelsk

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär  
Standard of care medications
Beskrivning

Standard of care medications

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

STATIN therapy prior to randomisation

Datatyp

boolean

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

STATIN therapy at randomisation

Datatyp

boolean

If no, indicate reason
Beskrivning

no STATIN therapy at randomisation reason

Datatyp

text

If other reason, specify:
Beskrivning

no STATIN therapy at randomisation other reason

Datatyp

text

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

ASPIRIN therapy prior to randomisation

Datatyp

boolean

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

ASPIRIN at randomisation

Datatyp

boolean

If no, indicate reason:
Beskrivning

no ASPIRIN at randomisation reason

Datatyp

text

If other reason, specify:
Beskrivning

no ASPIRIN at randomisation other reason

Datatyp

text

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

P2Y12 inhibitors

Datatyp

boolean

If no, indicate reason:
Beskrivning

no P2Y12 inhibitors reason

Datatyp

text

If other reason, specify:
Beskrivning

no P2Y12 inhibitors other reason

Datatyp

text

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

beta-blocker

Datatyp

boolean

If no, indicate reason:
Beskrivning

no beta-blocker reason

Datatyp

text

If other reason, specify:
Beskrivning

no beta-blocker other reason

Datatyp

text

7. Is the subject taking an ACE inhibitor?
Beskrivning

ACE inhibitor

Datatyp

boolean

If no, indicate reason:
Beskrivning

no ACE inhibitor reason

Datatyp

text

If other reason, specify:
Beskrivning

no ACE inhibitors other reason

Datatyp

text

8. Is the subject taking an ARB?
Beskrivning

ARB

Datatyp

boolean

If no, indicate reason:
Beskrivning

no ARB reason

Datatyp

text

If other reason, specify:
Beskrivning

no ARB other reason

Datatyp

text

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

renin-angiotensin-aldosterone system-targeted medication

Datatyp

boolean

If no, indicate reason:
Beskrivning

no renin-angiotensin-aldosterone system-targeted medication reason

Datatyp

text

If other reason, specify:
Beskrivning

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

Datatyp

text

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Similar models

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

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