ID

25066

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: Screening/Enrollment

Mots-clés

  1. 25/08/2017 25/08/2017 -
  2. 25/08/2017 25/08/2017 -
  3. 25/08/2017 25/08/2017 -
  4. 13/10/2017 13/10/2017 -
  5. 23/10/2017 23/10/2017 -
  6. 12/12/2017 12/12/2017 -
Téléchargé le

25 août 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0 Legacy

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Screening/Enrollment GSK study Chronic Coronary Heart Disease NCT00799903

Screening/Enrollment GSK study Chronic CHD NCT00799903

Screening
Description

Screening

1. Subject initials
Description

Subject initials

Type de données

text

2. Date of birth
Description

Date of birth

Type de données

date

3. eGFR value used for screening
Description

eGFR

Type de données

integer

4. Was this subject a screen failure?
Description

If Yes, check all that apply

Type de données

boolean

Reason for screen failure
Description

Reason for screen failure

[F01] Did not meet inclusion/exclusion criteria
Description

Inclusion exclusion criteria

Type de données

boolean

[F10] Subject withdrew consent prior to randomisation
Description

Withdrawal of consent

Type de données

boolean

[F06] Study closed/terminated prior to randomisation
Description

Study closed/terminated

Type de données

boolean

[F07] Lost to follow up prior to randomisation
Description

Lost to follow up

Type de données

boolean

[I02] Inclusion Criteria 2
Description

Inclusion Criteria 2

Type de données

boolean

[I03] Inclusion Criteria 3
Description

Inclusion Criteria 3

Type de données

boolean

[I04] Inclusion Criteria 4
Description

Inclusion Criteria 4

Type de données

boolean

[I05] Inclusion Criteria 5
Description

Inclusion Criteria 5

Type de données

boolean

[E01] Exclusion Criteria 1
Description

Exclusion Criteria 1

Type de données

boolean

[E02] Exclusion Criteria 2
Description

Exclusion Criteria 2

Type de données

boolean

[E03] Exclusion Criteria 3
Description

Exclusion Criteria 3

Type de données

boolean

[E04] Exclusion Criteria 4
Description

Exclusion Criteria 4

Type de données

boolean

[E05] Exclusion Criteria 5
Description

Exclusion Criteria 5

Type de données

boolean

[E06] Exclusion Criteria 6
Description

Exclusion Criteria 6

Type de données

boolean

[E07] Exclusion Criteria 7
Description

Exclusion Criteria 7

Type de données

boolean

[E08] Exclusion Criteria 8
Description

Exclusion Criteria 8

Type de données

boolean

[E09] Exclusion Criteria 9
Description

Exclusion Criteria 9

Type de données

boolean

[E10] Exclusion Criteria 10
Description

Exclusion Criteria 10

Type de données

boolean

[E11] Exclusion Criteria 11
Description

Exclusion Criteria 11

Type de données

boolean

[E12] Exclusion Criteria 12
Description

Exclusion Criteria 12

Type de données

boolean

[E13] Exclusion Criteria 13
Description

Exclusion Criteria 13

Type de données

boolean

[E14] Exclusion Criteria 14
Description

Exclusion Criteria 14

Type de données

boolean

[E15] Exclusion Criteria 15
Description

Exclusion Criteria 15

Type de données

boolean

[E16] Exclusion Criteria 16
Description

Exclusion Criteria 16

Type de données

boolean

[E16] Exclusion Criteria 16, specify:
Description

Exclusion Criteria 16, specification

Type de données

text

Enrollment
Description

Enrollment

1. Subject number
Description

Subject number

Type de données

text

Similar models

Screening/Enrollment GSK study Chronic CHD NCT00799903

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Screening
Subject initials
Item
1. Subject initials
text
Date of birth
Item
2. Date of birth
date
eGFR
Item
3. eGFR value used for screening
integer
screen failure
Item
4. Was this subject a screen failure?
boolean
Item Group
Reason for screen failure
Inclusion exclusion criteria
Item
[F01] Did not meet inclusion/exclusion criteria
boolean
Withdrawal of consent
Item
[F10] Subject withdrew consent prior to randomisation
boolean
Study closed/terminated
Item
[F06] Study closed/terminated prior to randomisation
boolean
Lost to follow up
Item
[F07] Lost to follow up prior to randomisation
boolean
Inclusion Criteria 2
Item
[I02] Inclusion Criteria 2
boolean
Inclusion Criteria 3
Item
[I03] Inclusion Criteria 3
boolean
Inclusion Criteria 4
Item
[I04] Inclusion Criteria 4
boolean
Inclusion Criteria 5
Item
[I05] Inclusion Criteria 5
boolean
Exclusion Criteria 1
Item
[E01] Exclusion Criteria 1
boolean
Exclusion Criteria 2
Item
[E02] Exclusion Criteria 2
boolean
Exclusion Criteria 3
Item
[E03] Exclusion Criteria 3
boolean
Exclusion Criteria 4
Item
[E04] Exclusion Criteria 4
boolean
Exclusion Criteria 5
Item
[E05] Exclusion Criteria 5
boolean
Exclusion Criteria 6
Item
[E06] Exclusion Criteria 6
boolean
Exclusion Criteria 7
Item
[E07] Exclusion Criteria 7
boolean
Exclusion Criteria 8
Item
[E08] Exclusion Criteria 8
boolean
Exclusion Criteria 9
Item
[E09] Exclusion Criteria 9
boolean
Exclusion Criteria 10
Item
[E10] Exclusion Criteria 10
boolean
Exclusion Criteria 11
Item
[E11] Exclusion Criteria 11
boolean
Exclusion Criteria 12
Item
[E12] Exclusion Criteria 12
boolean
Exclusion Criteria 13
Item
[E13] Exclusion Criteria 13
boolean
Exclusion Criteria 14
Item
[E14] Exclusion Criteria 14
boolean
Exclusion Criteria 15
Item
[E15] Exclusion Criteria 15
boolean
Exclusion Criteria 16
Item
[E16] Exclusion Criteria 16
boolean
Exclusion Criteria 16, specification
Item
[E16] Exclusion Criteria 16, specify:
text
Item Group
Enrollment
Subject number
Item
1. Subject number
text

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