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Vital Signs ×
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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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- 6/20/18 - 1 form, 2 itemgroups, 14 items, 2 languages
Itemgroups: General information,Vital Sign
- 11/26/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Administrative Data,Vital Signs
- 9/27/21 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Administrative Data,Vital Signs
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.
- 9/20/21 - 1 form, 16 itemgroups, 156 items, 1 language
Itemgroups: Date of visit, Assessment Date,Adverse Event; Concomitant Agent; Evaluation, Repeat,Liver, Adverse Event,Non-serious Adverse Event,Serious Adverse Event,Concomitant Agent,Laboratory Procedures,Vital signs,Pharmacokinetic aspect, Blood, Repeat,Pulmonary function tests, Repeat,Holter Electrocardiography, Repeat,Holter Electrocardiography, Abnormality, Repeat,Telemetry, Repeat,Telemetry, Abnormality, Repeat,12 lead ECG, Abnormality, Repeat,12 lead ECG

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