ID
33230
Beschreibung
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the 12-LEAD-ECG form. It has to be filled in for screening, study visit and follow up.
Link
https://clinicaltrials.gov/ct2/show/NCT00599612
Stichworte
Versionen (3)
- 28.11.18 28.11.18 -
- 01.12.18 01.12.18 -
- 03.12.18 03.12.18 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
3. Dezember 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612
12-Lead Electrocardiogram
- StudyEvent: ODM
Beschreibung
12-lead ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1623258
Beschreibung
For screening: ECG1-3 are mandatory for screening. ECG4-6 are possible as unscheduled. For study visit: ECG1-8 are paired at certain points in time, from ECG1 for pre-dose ECG to ECG8 at 24 h post-dose (See Item "planned relative Time", Codelist 3-10). ECG1-6 are possible as unscheduled. For Follow-up: ECG 1 is mandatory. ECG2 and 3 are possible as unscheduled.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1300638
- UMLS CUI [1,2]
- C0180600
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschreibung
3-10: It is only for study visit. 1, 2 and 11 as indicated.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0439564
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschreibung
Heart Rate
Datentyp
integer
Maßeinheiten
- Beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0430456
Beschreibung
PR Interval
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0429087
- UMLS CUI [1,2]
- C0430456
Beschreibung
QRS Duration
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0429025
- UMLS CUI [1,2]
- C0430456
Beschreibung
Uncorrected QT Interval
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C0430456
Beschreibung
QTc Interval
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0430456
Beschreibung
Complete the additional ECG Abnormalities page if clinically significant abnormalities are present. Additional for study visit and follow up: Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0430456
Ähnliche Modelle
12-Lead Electrocardiogram
- StudyEvent: ODM
C0678257 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])