ID
35044
Beschrijving
Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome
Trefwoorden
Versies (1)
- 12-02-19 12-02-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
12 februari 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080
Baseline - Vital Signs Pre-Dose; Subject's Food Intake; 12-Lead-ECG - Pre-Dose; Randomisation Number; Investigational Product; Vital Signs - Post-Dose
Beschrijving
Vital Signs - Pre-Dose
Alias
- UMLS CUI-1
- C0518766
Beschrijving
e.g. pre-dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
Beschrijving
Actual Time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Subject position
Datatype
integer
Alias
- UMLS CUI [1]
- C1262869
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Subject's Food Intake
Alias
- UMLS CUI-1
- C0518037
Beschrijving
12-Lead ECG - Pre-Dose
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Note: Perform ECGs in triplicate at least 2 hours after the subject’s last meal. Note: If abnormal, document abnormality in the Investigator Comment Log. Note: If any clinically significant abnormalities are still noted on pre-dose ECG, the subject is NOT eligible for the study. Check one:
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beschrijving
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Vital Signs - 2 Hours Post-Dose
Alias
- UMLS CUI-1
- C0518766
Beschrijving
e.g., 15 min
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
Beschrijving
Actual Time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Subject position
Datatype
integer
Alias
- UMLS CUI [1]
- C1262869
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Vital Signs - 4 Hours Post-Dose
Alias
- UMLS CUI-1
- C0518766
Beschrijving
e.g., 15 min
Datatype
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
Beschrijving
Actual Time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Subject position
Datatype
integer
Alias
- UMLS CUI [1]
- C1262869
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Similar models
Baseline - Vital Signs Pre-Dose; Subject's Food Intake; 12-Lead-ECG - Pre-Dose; Randomisation Number; Investigational Product; Vital Signs - Post-Dose
C0439564 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])