ID
28152
Beschrijving
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
Trefwoorden
Versies (4)
- 21-09-17 21-09-17 -
- 13-10-17 13-10-17 -
- 23-10-17 23-10-17 -
- 22-12-17 22-12-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
22 december 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Investigational product GSK study Chronic Coronary Heart Disease NCT00799903
Investigational product GSK study Chronic Coronary Heart Disease NCT00799903
Beschrijving
Investigational product discontinuation
Beschrijving
investigational product stopped permanently
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0457454
Beschrijving
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".
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0457454
Beschrijving
Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Check all that apply. If none, select "No Subreasons":
Datatype
boolean
Alias
- UMLS CUI [1]
- C2699517
Beschrijving
Adverse event MACE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C2826934
Beschrijving
Select this reason if none of the other primary reasons are appropriate.
Datatype
text
Alias
- UMLS CUI [1]
- C1705236
Beschrijving
Select this reason if none of the other primary reasons are appropriate.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Beschrijving
Sponsor terminated study treatment specification
Datatype
text
Alias
- UMLS CUI [1]
- C1710224
Beschrijving
Investigator site closed specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Post-IP Follow-up status
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0589121
- UMLS CUI [1,2]
- C0205272
Beschrijving
Fill in in case "Post-IP Phone Follow-up With Subject" or "Post-IP Follow-up through designated third party" has been selected.
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Contact frequency other
Datatype
text
Alias
- UMLS CUI [1]
- C0337611
Beschrijving
Authorization status
Datatype
text
Alias
- UMLS CUI [1,1]
- C0680281
- UMLS CUI [1,2]
- C0018724
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Investigational product GSK study Chronic Coronary Heart Disease NCT00799903
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
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C2826934 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,2])
C0018724 (UMLS CUI [1,2])