ID

28152

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: Investigational product

Keywords

Versions (4)
  1. 9/21/17 9/21/17 -
  2. 10/13/17 10/13/17 -
  3. 10/23/17 10/23/17 -
  4. 12/22/17 12/22/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 22, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Investigational product GSK study Chronic Coronary Heart Disease NCT00799903

English

Investigational product GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Investigational product (PK and/or PD)
Description

Investigational product (PK and/or PD)

1. Date of darapladib/placebo dose on day two days prior to PK and/or PD
Description

Date of darapladib/placebo dose two days

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
1. Time of darapladib/placebo dose on two days prior to PK and/or PD Hr:Min (00:00-23:59)
Description

Time of darapladib/placebo dose two days

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
2. Date of darapladib/placebo dose one day prior to PK and/or PD
Description

Date of darapladib/placebo dose one day

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
2. Time of darapladib/placebo dose one day prior to PK and/or PD Hr:Min (00:00-23:59)
Description

Time of darapladib/placebo dose one day

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Investigational product discontinuation
Description

Investigational product discontinuation

1. Was the investigational product stopped permanently before study reached GSK target number of primary clinical endpoints?
Description

investigational product stopped permanently

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
2. Select primary reason the investigational product was stopped
Description

Select "Protocol deviation" if none of the other primary reasons are appropriate. Select "Decision by subject or proxy" if none of the other primary reasons are appropriate. In case of "Adverse Event", record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Check all that apply. If none, select "No Subreasons".

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0457454
Adverse event: No subreasons
Description

Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Check all that apply. If none, select "No Subreasons":

Data type

boolean

Alias
UMLS CUI [1]
C2699517
Adverse event: MACE
Description

Adverse event MACE

Data type

boolean

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C2826934
If Protocol deviation, specify
Description

Select this reason if none of the other primary reasons are appropriate.

Data type

text

Alias
UMLS CUI [1]
C1705236
If Decision by subject or proxy, specify
Description

Select this reason if none of the other primary reasons are appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
If Sponsor terminated study treatment, specify
Description

Sponsor terminated study treatment specification

Data type

text

Alias
UMLS CUI [1]
C1710224
If Investigator site closed, specify
Description

Investigator site closed specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Post-IP Follow-up status
Description

Post-IP Follow-up status

1. Type of regular post-IP follow-up
Description

Select type [1] if telephone follow-up was accepted by subject. Please complete TELE visit form for each contact. In case of type [2], please complete THIRD PARTY visit form for each contact. In case of type [3], please complete CONC form within EOS visit.

Data type

integer

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C0205272
Contact Frequency
Description

Fill in in case "Post-IP Phone Follow-up With Subject" or "Post-IP Follow-up through designated third party" has been selected.

Data type

text

Alias
UMLS CUI [1]
C3476109
Other contact frequency, specify
Description

Contact frequency other

Data type

text

Alias
UMLS CUI [1]
C0337611
2. Did subject sign the Authorization for Release of Health Information or other site medical release form for follow-up on medical information?
Description

Authorization status

Data type

text

Alias
UMLS CUI [1,1]
C0680281
UMLS CUI [1,2]
C0018724
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Similar models

Investigational product GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigational product (PK and/or PD)
Date of darapladib/placebo dose two days
Item
1. Date of darapladib/placebo dose on day two days prior to PK and/or PD
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of darapladib/placebo dose two days
Item
1. Time of darapladib/placebo dose on two days prior to PK and/or PD Hr:Min (00:00-23:59)
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of darapladib/placebo dose one day
Item
2. Date of darapladib/placebo dose one day prior to PK and/or PD
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of darapladib/placebo dose one day
Item
2. Time of darapladib/placebo dose one day prior to PK and/or PD Hr:Min (00:00-23:59)
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Investigational product discontinuation
Item
1. Was the investigational product stopped permanently before study reached GSK target number of primary clinical endpoints?
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
investigational product stopped permanently
Code List
1. Was the investigational product stopped permanently before study reached GSK target number of primary clinical endpoints?
CL Item
No (N)
CL Item
Yes, complete primary reason (Y)
Item
2. Select primary reason the investigational product was stopped
text
C0392360 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
investigational product discontinuation reason
Code List
2. Select primary reason the investigational product was stopped
CL Item
Adverse event (1)
C0877248 (UMLS CUI-1)
(Comment:en)
CL Item
Study closed/terminated (5)
C2348570 (UMLS CUI-1)
(Comment:en)
CL Item
Lost to follow-up (6)
C1302313 (UMLS CUI-1)
(Comment:en)
CL Item
Protocol deviation (3)
C1705236 (UMLS CUI-1)
(Comment:en)
CL Item
Decision by subject or proxy (8)
C0679006 (UMLS CUI-1)
(Comment:en)
CL Item
Sponsor terminated study treatment, specify (9)
C1710224 (UMLS CUI-1)
(Comment:en)
CL Item
Investigator site closed (10)
C0035173 (UMLS CUI-1)
(Comment:en)
Adverse event No subreasons
Item
Adverse event: No subreasons
boolean
C2699517 (UMLS CUI [1])
Adverse event MACE
Item
Adverse event: MACE
boolean
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
Protocol deviation specification
Item
If Protocol deviation, specify
text
C1705236 (UMLS CUI [1])
Decision by subject or proxy specification
Item
If Decision by subject or proxy, specify
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Sponsor terminated study treatment specification
Item
If Sponsor terminated study treatment, specify
text
C1710224 (UMLS CUI [1])
Investigator site closed specification
Item
If Investigator site closed, specify
text
C2348235 (UMLS CUI [1])
Item Group
Post-IP Follow-up status
Item
1. Type of regular post-IP follow-up
integer
C0589121 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Type of regular post-IP follow-up
Code List
1. Type of regular post-IP follow-up
CL Item
Post-IP Phone Follow-up With Subject (1)
CL Item
Post-IP Follow-up through designated third party such as friend, family member, physician or medical records (2)
CL Item
No longer ongoing in study (e.g. Withdraw of consent, Lost to Follow-up, Death) (3)
Item
Contact Frequency
text
C3476109 (UMLS CUI [1])
Contact Frequency
Code List
Contact Frequency
CL Item
Every 3 months (preferred frequency per protocol) ([1])
CL Item
Every 6 months (only if regular follow-up refused) ([2])
CL Item
Every 12 months (only if regular follow-up refused) ([3])
CL Item
Every 18 months (only if regular follow-up refused) ([4])
CL Item
End of study only (only if regular follow-up refused) ([5])
CL Item
Other ([OT])
Contact frequency other
Item
Other contact frequency, specify
text
C0337611 (UMLS CUI [1])
Item
2. Did subject sign the Authorization for Release of Health Information or other site medical release form for follow-up on medical information?
text
C0680281 (UMLS CUI [1,1])
C0018724 (UMLS CUI [1,2])
Authorization status
Code List
2. Did subject sign the Authorization for Release of Health Information or other site medical release form for follow-up on medical information?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not applicable (e.g. additional consent for release of medical information not required) (X)
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