ID

28052

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: ABPM Substudy.

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GlaxoSmithKline

Hochgeladen am

12. Dezember 2017

DOI

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ABPM Substudy GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

ABPM Substudy GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
ABPM Substudy Participation
Beschreibung

ABPM Substudy Participation

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

ABPM substudy participation

Datentyp

boolean

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

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.

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

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).

Datentyp

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.
Beschreibung

changes in antihypertensive medications

Datentyp

boolean

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

Current atrial fibrillation

Datentyp

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.
Beschreibung

expected change in antihypertensive medication

Datentyp

boolean

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

upper arm diameter of >42 cm

Datentyp

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.
Beschreibung

night time work

Datentyp

boolean

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

Other specification

Datentyp

text

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

Medical condition - ABPM substudy

1. Chronic kidney disease
Beschreibung

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

Datentyp

integer

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

ABPM substudy

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

ABPM device placed on subject

Datentyp

boolean

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

Date of placement of ABPM device

Datentyp

date

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

No placement of ABPM device reason

Datentyp

text

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

ABPM data capture success

Datentyp

boolean

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

ABPM for 24 hours

Datentyp

boolean

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

repetition of ABPM

Datentyp

boolean

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

no repetition of ABPM reason

Datentyp

text

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

ABPM substudy - Repeat assessments

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

ABPM device placed on subject repeat

Datentyp

boolean

Alias
UMLS CUI [1]
C0026426
Yes, date
Beschreibung

Date of placement of ABPM device repeat

Datentyp

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
Beschreibung

No placement of ABPM device reason repeat

Datentyp

text

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

ABPM data capture success repeat

Datentyp

boolean

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

ABPM for 24 hours repeat

Datentyp

boolean

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

repetition of ABPM repeat

Datentyp

boolean

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

no repetition of ABPM reason repeat

Datentyp

text

Alias
UMLS CUI [1]
C0026426
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Ähnliche Modelle

ABPM Substudy GSK study Chronic Coronary Heart Disease NCT00799903

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