ID

26688

Descripción

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

Palabras clave

Versiones (4)
  1. 21/9/17 21/9/17 -
  2. 13/10/17 13/10/17 -
  3. 23/10/17 23/10/17 -
  4. 22/12/17 22/12/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

23 de octubre de 2017

DOI

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Licencia

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

Inglés

Investigational product GSK study Chronic Coronary Heart Disease NCT00799903

1 formularios  
Investigational product (PK and/or PD)
Descripción

Investigational product (PK and/or PD)

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

Date of darapladib/placebo dose two days

Tipo de datos

date

1. Time of darapladib/placebo dose on two days prior to PK and/or PD Hr:Min (00:00-23:59)
Descripción

Time of darapladib/placebo dose two days

Tipo de datos

time

2. Date of darapladib/placebo dose one day prior to PK and/or PD
Descripción

Date of darapladib/placebo dose one day

Tipo de datos

date

2. Time of darapladib/placebo dose one day prior to PK and/or PD Hr:Min (00:00-23:59)
Descripción

Time of darapladib/placebo dose one day

Tipo de datos

time

Investigational product discontinuation
Descripción

Investigational product discontinuation

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

investigational product stopped permanently

Tipo de datos

text

2. Select primary reason the investigational product was stopped
Descripción

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".

Tipo de datos

text

Adverse event: No subreasons
Descripción

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

Tipo de datos

boolean

Adverse event: MACE
Descripción

Adverse event MACE

Tipo de datos

boolean

If Protocol deviation, specify
Descripción

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

Tipo de datos

text

If Decision by subject or proxy, specify
Descripción

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

Tipo de datos

text

If Sponsor terminated study treatment, specify
Descripción

Sponsor terminated study treatment specification

Tipo de datos

text

If Investigator site closed, specify
Descripción

Investigator site closed specification

Tipo de datos

text

Post-IP Follow-up status
Descripción

Post-IP Follow-up status

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

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.

Tipo de datos

integer

Contact Frequency
Descripción

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

Tipo de datos

text

Other contact frequency, specify
Descripción

Contact frequency other

Tipo de datos

text

2. Did subject sign the Authorization for Release of Health Information or other site medical release form for follow-up on medical information?
Descripción

Authorization status

Tipo de datos

text

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Similar models

Investigational product GSK study Chronic Coronary Heart Disease NCT00799903

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
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
Date of darapladib/placebo dose one day
Item
2. Date of darapladib/placebo dose one day prior to PK and/or PD
date
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
Item Group
Investigational product discontinuation
Item
1. Was the investigational product stopped permanently before study reached GSK target number of primary clinical endpoints?
text
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
investigational product discontinuation reason
Code List
2. Select primary reason the investigational product was stopped
CL Item
Adverse event (1)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Protocol deviation (3)
CL Item
Decision by subject or proxy (8)
CL Item
Sponsor terminated study treatment, specify (9)
CL Item
Investigator site closed (10)
Adverse event No subreasons
Item
Adverse event: No subreasons
boolean
Adverse event MACE
Item
Adverse event: MACE
boolean
Protocol deviation specification
Item
If Protocol deviation, specify
text
Decision by subject or proxy specification
Item
If Decision by subject or proxy, specify
text
Sponsor terminated study treatment specification
Item
If Sponsor terminated study treatment, specify
text
Investigator site closed specification
Item
If Investigator site closed, specify
text
Item Group
Post-IP Follow-up status
Item
1. Type of regular post-IP follow-up
integer
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
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
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
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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