ID

25152

Beschreibung

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

Stichworte

Versionen (3)
  1. 27.08.17 27.08.17 -
  2. 23.10.17 23.10.17 -
  3. 12.12.17 12.12.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

27. August 2017

DOI

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

Englisch

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
Standard of care medications
Beschreibung

Standard of care medications

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

STATIN therapy prior to randomisation

Datentyp

boolean

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

STATIN therapy at randomisation

Datentyp

boolean

If no, indicate reason
Beschreibung

no STATIN therapy at randomisation reason

Datentyp

text

If other reason, specify:
Beschreibung

no STATIN therapy at randomisation other reason

Datentyp

text

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

ASPIRIN therapy prior to randomisation

Datentyp

boolean

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

ASPIRIN at randomisation

Datentyp

boolean

If no, indicate reason:
Beschreibung

no ASPIRIN at randomisation reason

Datentyp

text

If other reason, specify:
Beschreibung

no ASPIRIN at randomisation other reason

Datentyp

text

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

P2Y12 inhibitors

Datentyp

boolean

If no, indicate reason:
Beschreibung

no P2Y12 inhibitors reason

Datentyp

text

If other reason, specify:
Beschreibung

no P2Y12 inhibitors other reason

Datentyp

text

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

beta-blocker

Datentyp

boolean

If no, indicate reason:
Beschreibung

no beta-blocker reason

Datentyp

text

If other reason, specify:
Beschreibung

no beta-blocker other reason

Datentyp

text

7. Is the subject taking an ACE inhibitor?
Beschreibung

ACE inhibitor

Datentyp

boolean

If no, indicate reason:
Beschreibung

no ACE inhibitor reason

Datentyp

text

If other reason, specify:
Beschreibung

no ACE inhibitors other reason

Datentyp

text

8. Is the subject taking an ARB?
Beschreibung

ARB

Datentyp

boolean

If no, indicate reason:
Beschreibung

no ARB reason

Datentyp

text

If other reason, specify:
Beschreibung

no ARB other reason

Datentyp

text

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

renin-angiotensin-aldosterone system-targeted medication

Datentyp

boolean

If no, indicate reason:
Beschreibung

no renin-angiotensin-aldosterone system-targeted medication reason

Datentyp

text

If other reason, specify:
Beschreibung

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

Datentyp

text

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Ähnliche Modelle

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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