ID
38858
Descrição
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 subject's ECG and should be filled out at Visit 1, 6, 7 (10h), EW, Day 7 Follow Up and Day 14 Follow Up and can be repeated in "logs/repeats" (unscheduled).
Link
https://clinicaltrials.gov/ct2/show/NCT00992160
Palavras-chave
Versões (3)
- 24/02/2019 24/02/2019 -
- 01/03/2019 01/03/2019 -
- 10/11/2019 10/11/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
10 de novembro de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
12-Lead-ECG
- StudyEvent: ODM
Descrição
Dosing Date and Time
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C1264639
Descrição
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Descrição
At Visit 1 / Screening, select "Measurement 1". At Visit 6 and EW, select "Timepoint 1". At Visit 7, select "10h". For all other visits, skip this item.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0242485
- UMLS CUI [1,2]
- C0332307
Descrição
ECG Date/Time
Tipo de dados
datetime
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1264639
Descrição
If Abnormal - Clinically significant: complete the AE form if the abnormality meets the protocol definition for an AE
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0438154
Similar models
12-Lead-ECG
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])