ID

25852

Descrizione

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

versioni (4)
  1. 21/09/17 21/09/17 -
  2. 13/10/17 13/10/17 -
  3. 23/10/17 23/10/17 -
  4. 22/12/17 22/12/17 -
Titolare del copyright

GlaxoSmithKline

Caricato su

21 settembre 2017

DOI

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Licenza

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

Inglese

Investigational product GSK study Chronic Coronary Heart Disease NCT00799903

1 moduli  
Investigational product (PK and/or PD)
Descrizione

Investigational product (PK and/or PD)

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

Date of darapladib/placebo dose two days

Tipo di dati

date

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

Time of darapladib/placebo dose two days

Tipo di dati

time

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

Date of darapladib/placebo dose one day

Tipo di dati

date

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

Time of darapladib/placebo dose one day

Tipo di dati

time

Investigational product discontinuation
Descrizione

Investigational product discontinuation

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

investigational product stopped permanently

Tipo di dati

text

2. Select primary reason the investigational product was stopped
Descrizione

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 di dati

text

Adverse event: No subreasons
Descrizione

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 di dati

boolean

Adverse event: MACE
Descrizione

Adverse event MACE

Tipo di dati

boolean

If Protocol deviation, specify
Descrizione

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

Tipo di dati

text

If Decision by subject or proxy, specify
Descrizione

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

Tipo di dati

text

If Sponsor terminated study treatment, specify
Descrizione

Sponsor terminated study treatment specification

Tipo di dati

text

If Investigator site closed, specify
Descrizione

Investigator site closed specification

Tipo di dati

text

Post-IP Follow-up status
Descrizione

Post-IP Follow-up status

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

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 di dati

integer

Contact Frequency
Descrizione

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

Tipo di dati

text

Other contact frequency, specify
Descrizione

Contact frequency other

Tipo di dati

text

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

Authorization status

Tipo di dati

text

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Similar models

Investigational product GSK study Chronic Coronary Heart Disease NCT00799903

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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