ID
38855
Beschrijving
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 unscheduled vital sign measurements. There is a seperate form for scheduled measurements. All vital signs should be taken in a sitting position.
Link
https://clinicaltrials.gov/ct2/show/NCT00992160
Trefwoorden
Versies (2)
- 10-11-19 10-11-19 -
- 27-09-21 27-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
10 november 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Logs/Repeats Vital Signs
- StudyEvent: ODM
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Vital Signs Date/Time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0518766
Beschrijving
If done, record systolic/diastolic value in next items.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3826646
- UMLS CUI [1,2]
- C1272696
Beschrijving
Blood pressure Systolic
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Blood pressure Diastolic
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
If done, record result in next item.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C1272696
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
If done, record result in next item.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0231832
- UMLS CUI [1,2]
- C3841220
Beschrijving
Respiration rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
If done, record result in next item.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C1272696
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Similar models
Logs/Repeats Vital Signs
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0518766 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])