Information:
Fel:
ID
38828
Beskrivning
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders
Nyckelord
Versioner (1)
- 2019-11-07 2019-11-07 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
7 november 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597
Screening - Administrative; Demography; Vital Signs; 12-Lead ECG; Summary Holter
Similar models
Screening - Administrative; Demography; Vital Signs; 12-Lead ECG; Summary Holter
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1,1])
C0020155 (UMLS CUI [1,2])
C0020155 (UMLS CUI [1,2])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Female (F)
CL Item
Male (M)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Planned Relative Time - Vital Signs
Item
Planned Relative Time - Vital Signs
text
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,3])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure Semi-recumbent
Item
Systolic Blood Pressure Semi-recumbent
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure Semi-recumbent
Item
Diastolic Blood Pressure Semi-recumbent
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
CL Item
ECG 1 (1)
CL Item
ECG 2 (2)
CL Item
ECG 3 (3)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Planned Relative Time - ECG
Item
Planned Relative Time - ECG
text
C0430456 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Start date of Holter
Item
Start date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start time of Holter
Item
Start time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Stop date of Holter
Item
Stop date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Stop time of Holter
Item
Stop time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item
Interpretation of Holter
text
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
C0438154 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant 1 (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
CL Item
12 Lead 1000Hz (1)
CL Item
12 lead 180Hz (2)
CL Item
3 Lead 180 Hz (3)
CL Item
Telemetry (4)
CL Item
5 Lead 512Hz (5)
CL Item
4 Lead 0.05-40 Hz (6)
CL Item
6 Lead 0.05-40 Hz (7)
CL Item
7 Lead 0.05-100 Hz-3dB (8)
CL Item
7 Lead 3 channel 133 Hz (9)
CL Item
2 Lead 200 Hz (10)
CL Item
Other (11)
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