ID
38854
Beskrivning
Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). The purpose of this form is to record the results of the vital sign measurement and should be filled out at Visits 1 to 8, Day 7 and Day 14 Follow-Up and in case of Early Withdrawal. There is a seperate form for unscheduled repeat measurements. All vital signs should be taken in a sitting position.
Länk
https://clinicaltrials.gov/ct2/show/NCT00992160
Nyckelord
Versioner (3)
- 2019-02-23 2019-02-23 -
- 2019-03-01 2019-03-01 -
- 2019-11-10 2019-11-10 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
10 november 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Vital Signs
- StudyEvent: ODM
Beskrivning
Dosing Date and Time
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C1264639
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
At Visit 1 / Screening, select "Measurement 1". At Visit 2 to 5, 7 and 8, fill in itemgroup both for "Pre-dose" and "10h". For all other visits, skip this item.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0332307
Beskrivning
Vital Signs Date/Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0518766
Beskrivning
Applicable to Visit 1 only
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Applicable to Visit 1 only
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Applicable to Visit 1 only
Datatyp
float
Måttenheter
- kg/m^2
Alias
- UMLS CUI [1]
- C1305855
Beskrivning
Blood pressure Systolic
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Blood pressure Diastolic
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Respiration rate
Datatyp
integer
Måttenheter
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beskrivning
Oral temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0442027
Similar models
Vital Signs
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0518766 (UMLS CUI [1,2])
C0442027 (UMLS CUI [1,2])