ID

26682

Descrizione

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

versioni (3)
  1. 27/08/17 27/08/17 -
  2. 23/10/17 23/10/17 -
  3. 12/12/17 12/12/17 -
Titolare del copyright

GlaxoSmithKline

Caricato su

23 ottobre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

1 moduli  
Standard of care medications
Descrizione

Standard of care medications

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

STATIN therapy prior to randomisation

Tipo di dati

boolean

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

STATIN therapy at randomisation

Tipo di dati

boolean

If no, indicate reason
Descrizione

no STATIN therapy at randomisation reason

Tipo di dati

text

If other reason, specify:
Descrizione

no STATIN therapy at randomisation other reason

Tipo di dati

text

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

ASPIRIN therapy prior to randomisation

Tipo di dati

boolean

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

ASPIRIN at randomisation

Tipo di dati

boolean

If no, indicate reason:
Descrizione

no ASPIRIN at randomisation reason

Tipo di dati

text

If other reason, specify:
Descrizione

no ASPIRIN at randomisation other reason

Tipo di dati

text

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

P2Y12 inhibitors

Tipo di dati

boolean

If no, indicate reason:
Descrizione

no P2Y12 inhibitors reason

Tipo di dati

text

If other reason, specify:
Descrizione

no P2Y12 inhibitors other reason

Tipo di dati

text

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

beta-blocker

Tipo di dati

boolean

If no, indicate reason:
Descrizione

no beta-blocker reason

Tipo di dati

text

If other reason, specify:
Descrizione

no beta-blocker other reason

Tipo di dati

text

7. Is the subject taking an ACE inhibitor?
Descrizione

ACE inhibitor

Tipo di dati

boolean

If no, indicate reason:
Descrizione

no ACE inhibitor reason

Tipo di dati

text

If other reason, specify:
Descrizione

no ACE inhibitors other reason

Tipo di dati

text

8. Is the subject taking an ARB?
Descrizione

ARB

Tipo di dati

boolean

If no, indicate reason:
Descrizione

no ARB reason

Tipo di dati

text

If other reason, specify:
Descrizione

no ARB other reason

Tipo di dati

text

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

renin-angiotensin-aldosterone system-targeted medication

Tipo di dati

boolean

If no, indicate reason:
Descrizione

no renin-angiotensin-aldosterone system-targeted medication reason

Tipo di dati

text

If other reason, specify:
Descrizione

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

Tipo di dati

text

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Similar models

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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