ID

29505

Description

Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Study Conclusion

Keywords

Versions (1)
  1. 4/4/18 4/4/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 4, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257

English

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

Alias
UMLS CUI [1]
C2983670
Time of withdrawal
Description

Time of withdrawal

Data type

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Was the subject withdrawn from the study?
Description

subject withdrawn from the study

Data type

boolean

Alias
UMLS CUI [1]
C0422727
If Yes, check the primary reason for withdrawal:
Description

reason for withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If Other reason for withdrawal, specify
Description

reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Pregnancy information
Description

Pregnancy information

Alias
UMLS CUI-1
C0032961
Did the subject become pregnant during the study?
Description

If Yes, complete Pregnancy Notification form.

Data type

integer

Alias
UMLS CUI [1]
C0032961
Did a female partner of the male subject become pregnant during the study?
Description

If Yes, complete Pregnancy Notification form.

Data type

integer

Alias
UMLS CUI [1]
C0919624
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Time of withdrawal
Item
Time of withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
subject withdrawn from the study
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If Yes, check the primary reason for withdrawal:
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason for withdrawal
Code List
If Yes, check the primary reason for withdrawal:
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Other, specify (5)
reason for withdrawal
Item
If Other reason for withdrawal, specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Item
Did the subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did the subject become pregnant during the study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item
Did a female partner of the male subject become pregnant during the study?
integer
C0919624 (UMLS CUI [1])
female partner of the male subject become pregnant
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (subject is female, female partner not of childbearing potential or no female partner) (3)
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