ID

28052

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: ABPM Substudy.

Mots-clés

Versions (4)
  1. 15/09/2017 15/09/2017 -
  2. 13/10/2017 13/10/2017 -
  3. 23/10/2017 23/10/2017 -
  4. 12/12/2017 12/12/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

12 décembre 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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ABPM Substudy GSK study Chronic Coronary Heart Disease NCT00799903

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ABPM Substudy GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulaires  
ABPM Substudy Participation
Description

ABPM Substudy Participation

1. Is the subject participating in the ABPM substudy?
Description

ABPM substudy participation

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
No, select the reason why the subject is not participating in the ABPM substudy
Description

In case of "Inclusion [I] / exclusion [E] criteria", choose any criteria that apply in the following. In case of "Other", please specify in the following.

Type de données

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
[I06] ABPM 1. Signed written informed consent prior to beginning substudy-related procedures (subject must understand the aims, investigational procedures and possible consequences of the substudy).
Description

Note: Consent to participate in the substudy is separate from consent to participate in the parent study.

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
[I07] ABPM 2. Subjects must meet the following BP criteria one day before the parent study Baseline Visit. Subjects without diabetes mellitus or chronic kidney disease: BP <140/90mmHg. Subjects with diabetes mellitus or chronic kidney disease: BP <130/80mmHg.
Description

Chronic kidney disease is defined by either: reduced excretory function with an eGFR <60 mL/min per 1.73m2 (corresponding approximately to a creatinine of >1.5 mg/dL [132.6 S?mol/L] in men or >1.3 mg/dL [114.9 S?mol/L] in women) OR the presence of albuminuria (>300 mg/day or 200 mg albumin per gram of creatinine).

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0243161
[E17] ABPM 1. Any changes in antihypertensive medications within the past 6 weeks.
Description

changes in antihypertensive medications

Type de données

boolean

Alias
UMLS CUI [1]
C0003364
[E18] ABPM 2. Current atrial fibrillation.
Description

Current atrial fibrillation

Type de données

boolean

Alias
UMLS CUI [1]
C0004238
[E19] ABPM 3. Subjects who are expected to require a change in antihypertensive medication prior to the Month 3 visit.
Description

expected change in antihypertensive medication

Type de données

boolean

Alias
UMLS CUI [1]
C0003364
[E20] ABPM 4. Subjects with an upper arm diameter of >42 cm.
Description

upper arm diameter of >42 cm

Type de données

boolean

Alias
UMLS CUI [1,1]
C0446516
UMLS CUI [1,2]
C0332520
[E21] ABPM 5. Subjects who work at night or whose work schedule includes rotating night time (10:00 PM to 6:00 AM) work.
Description

night time work

Type de données

boolean

Alias
UMLS CUI [1,1]
C1658633
UMLS CUI [1,2]
C1659095
[OT] Other, specify
Description

Other specification

Type de données

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Medical condition - ABPM substudy
Description

Medical condition - ABPM substudy

1. Chronic kidney disease
Description

>300 mg/day or 200 mg albumin per gram of creatinine OR eGFR <60 mL//min per 1.73m2

Type de données

integer

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
ABPM substudy
Description

ABPM substudy

1. Was the ABPM device placed on the subject?
Description

ABPM device placed on subject

Type de données

boolean

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0439841
Yes, date
Description

Date of placement of ABPM device

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C0026426
No, provide reason
Description

No placement of ABPM device reason

Type de données

text

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0025080
2. Was the ABPM data capture successful?
Description

ABPM data capture success

Type de données

boolean

Alias
UMLS CUI [1,1]
C3258067
UMLS CUI [1,2]
C0025080
If not succesful, did the subject wear the ABPM for 24 hours?
Description

ABPM for 24 hours

Type de données

boolean

Alias
UMLS CUI [1]
C0026426
If not succesful, will the ABPM be repeated?
Description

repetition of ABPM

Type de données

boolean

Alias
UMLS CUI [1,1]
C0589243
UMLS CUI [1,2]
C0026426
If no repetition, provide reason
Description

no repetition of ABPM reason

Type de données

text

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C0205341
ABPM substudy - Repeat assessments
Description

ABPM substudy - Repeat assessments

1. Was the ABPM device placed on the subject?
Description

ABPM device placed on subject repeat

Type de données

boolean

Alias
UMLS CUI [1]
C0026426
Yes, date
Description

Date of placement of ABPM device repeat

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0026426
UMLS CUI [1,3]
C0025080
UMLS CUI [1,4]
C0021107
No, provide reason
Description

No placement of ABPM device reason repeat

Type de données

text

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C0026426
2. Was the ABPM data capture successful?
Description

ABPM data capture success repeat

Type de données

boolean

Alias
UMLS CUI [1]
C0026426
If not succesful, did the subject wear the ABPM for 24 hours?
Description

ABPM for 24 hours repeat

Type de données

boolean

Alias
UMLS CUI [1]
C0026426
If not succesful, will the ABPM be repeated?
Description

repetition of ABPM repeat

Type de données

boolean

Alias
UMLS CUI [1]
C0026426
If no repetition, provide reason
Description

no repetition of ABPM reason repeat

Type de données

text

Alias
UMLS CUI [1]
C0026426
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Similar models

ABPM Substudy GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
ABPM Substudy Participation
ABPM substudy participation
Item
1. Is the subject participating in the ABPM substudy?
boolean
C2348568 (UMLS CUI [1])
Item
No, select the reason why the subject is not participating in the ABPM substudy
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
no participation reason
Code List
No, select the reason why the subject is not participating in the ABPM substudy
CL Item
Inclusion [I] / exclusion [E] criteria ([1])
CL Item
Site nor participating ([2])
CL Item
Other ([OT])
Informed consent
Item
[I06] ABPM 1. Signed written informed consent prior to beginning substudy-related procedures (subject must understand the aims, investigational procedures and possible consequences of the substudy).
boolean
C0021430 (UMLS CUI [1])
BP criteria
Item
[I07] ABPM 2. Subjects must meet the following BP criteria one day before the parent study Baseline Visit. Subjects without diabetes mellitus or chronic kidney disease: BP <140/90mmHg. Subjects with diabetes mellitus or chronic kidney disease: BP <130/80mmHg.
boolean
C0005823 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
changes in antihypertensive medications
Item
[E17] ABPM 1. Any changes in antihypertensive medications within the past 6 weeks.
boolean
C0003364 (UMLS CUI [1])
Current atrial fibrillation
Item
[E18] ABPM 2. Current atrial fibrillation.
boolean
C0004238 (UMLS CUI [1])
expected change in antihypertensive medication
Item
[E19] ABPM 3. Subjects who are expected to require a change in antihypertensive medication prior to the Month 3 visit.
boolean
C0003364 (UMLS CUI [1])
upper arm diameter of >42 cm
Item
[E20] ABPM 4. Subjects with an upper arm diameter of >42 cm.
boolean
C0446516 (UMLS CUI [1,1])
C0332520 (UMLS CUI [1,2])
night time work
Item
[E21] ABPM 5. Subjects who work at night or whose work schedule includes rotating night time (10:00 PM to 6:00 AM) work.
boolean
C1658633 (UMLS CUI [1,1])
C1659095 (UMLS CUI [1,2])
Other specification
Item
[OT] Other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Medical condition - ABPM substudy
Item
1. Chronic kidney disease
integer
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
Chronic kidney disease
Code List
1. Chronic kidney disease
CL Item
Current (1)
CL Item
No medical condition (5)
Item Group
ABPM substudy
ABPM device placed on subject
Item
1. Was the ABPM device placed on the subject?
boolean
C0026426 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
Date of placement of ABPM device
Item
Yes, date
date
C0011008 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C0026426 (UMLS CUI [1,3])
No placement of ABPM device reason
Item
No, provide reason
text
C0026426 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
ABPM data capture success
Item
2. Was the ABPM data capture successful?
boolean
C3258067 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
ABPM for 24 hours
Item
If not succesful, did the subject wear the ABPM for 24 hours?
boolean
C0026426 (UMLS CUI [1])
repetition of ABPM
Item
If not succesful, will the ABPM be repeated?
boolean
C0589243 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
no repetition of ABPM reason
Item
If no repetition, provide reason
text
C0026426 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item Group
ABPM substudy - Repeat assessments
ABPM device placed on subject repeat
Item
1. Was the ABPM device placed on the subject?
boolean
C0026426 (UMLS CUI [1])
Date of placement of ABPM device repeat
Item
Yes, date
date
C0011008 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C0021107 (UMLS CUI [1,4])
No placement of ABPM device reason repeat
Item
No, provide reason
text
C0025080 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
ABPM data capture success repeat
Item
2. Was the ABPM data capture successful?
boolean
C0026426 (UMLS CUI [1])
ABPM for 24 hours repeat
Item
If not succesful, did the subject wear the ABPM for 24 hours?
boolean
C0026426 (UMLS CUI [1])
repetition of ABPM repeat
Item
If not succesful, will the ABPM be repeated?
boolean
C0026426 (UMLS CUI [1])
no repetition of ABPM reason repeat
Item
If no repetition, provide reason
text
C0026426 (UMLS CUI [1])
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