ID
35024
Description
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
Keywords
Versions (1)
- 2/10/19 2/10/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 10, 2019
DOI
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License
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
Screening - Demography; Vital Signs; Cardiovascular medical Conditions; Cardiovascular surgical Procedures; Medical Conditions
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Check one
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Check all that apply
Data type
integer
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Blood Pressure and Heart Rate
Alias
- UMLS CUI-1
- C0005823
- UMLS CUI-2
- C0018810
Description
Systolic Blood Pressure
Data type
float
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Subject Position
Data type
integer
Alias
- UMLS CUI [1]
- C1262869
Description
Heart Rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Cardiovascular Medical Conditions
Alias
- UMLS CUI-1
- C0007222
Description
1. Myocardial infarction
Data type
integer
Alias
- UMLS CUI [1]
- C0027051
Description
2. Ischaemic heart disease
Data type
integer
Alias
- UMLS CUI [1]
- C1869045
Description
3. Stable angina pectoris
Data type
integer
Alias
- UMLS CUI [1,1]
- C0002962
- UMLS CUI [1,2]
- C0340288
Description
4. Unstable angina
Data type
integer
Alias
- UMLS CUI [1]
- C0002965
Description
5. Atherosclerosis
Data type
integer
Alias
- UMLS CUI [1]
- C0004153
Description
6. Valvular heart disease NOS
Data type
integer
Alias
- UMLS CUI [1]
- C0018824
Description
7. Peripheral vascular disease
Data type
integer
Alias
- UMLS CUI [1]
- C0085096
Description
8. Cerebrovascular disorder
Data type
integer
Alias
- UMLS CUI [1]
- C0007820
Description
9. Transient ischaemic attack
Data type
integer
Alias
- UMLS CUI [1]
- C0007787
Description
10. Stroke
Data type
integer
Alias
- UMLS CUI [1]
- C0038454
Description
11. Cardiac arrest
Data type
integer
Alias
- UMLS CUI [1]
- C0018790
Description
12. Coronary artery disease
Data type
integer
Alias
- UMLS CUI [1]
- C1956346
Description
13. Heart failure
Data type
integer
Alias
- UMLS CUI [1]
- C0018801
Description
14. Arrhythmia
Data type
integer
Alias
- UMLS CUI [1]
- C0003811
Description
15. Left ventricular dysfunction
Data type
integer
Alias
- UMLS CUI [1]
- C0242698
Description
16. Pulmonary oedema
Data type
integer
Alias
- UMLS CUI [1]
- C0034063
Description
17. Hypertension
Data type
integer
Alias
- UMLS CUI [1]
- C0020538
Description
18. Oedema
Data type
integer
Alias
- UMLS CUI [1]
- C0013604
Description
19. Left ventricular hypertrophy
Data type
integer
Alias
- UMLS CUI [1]
- C0149721
Description
20. Cardiomegaly
Data type
integer
Alias
- UMLS CUI [1]
- C0018800
Description
21. Cardiomyopathy
Data type
integer
Alias
- UMLS CUI [1]
- C0878544
Description
22. Diastolic dysfunction
Data type
integer
Alias
- UMLS CUI [1]
- C0520863
Description
Cardiovascular Surgical Procedures
Alias
- UMLS CUI-1
- C1320716
- UMLS CUI-2
- C0543467
Description
1. Coronary artery bypass
Data type
text
Alias
- UMLS CUI [1]
- C0010055
Description
2. Angioplasty
Data type
text
Alias
- UMLS CUI [1]
- C0162577
Description
3. STENT insertion
Data type
text
Alias
- UMLS CUI [1]
- C0038257
Description
4. Cardiac transplantation
Data type
text
Alias
- UMLS CUI [1]
- C0018823
Description
5. Amputation
Data type
text
Alias
- UMLS CUI [1]
- C0002688
Description
6. Pacemaker insertion
Data type
text
Alias
- UMLS CUI [1]
- C0189843
Description
7. Carotid endarterectomy
Data type
text
Alias
- UMLS CUI [1]
- C0014099
Description
8. Vascular bypass graft
Data type
text
Alias
- UMLS CUI [1]
- C0863745
Description
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Description
1. Blood and lymphatic system disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0851353
Description
2. Ear and labyrinth disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0851354
Description
3. Endocrine disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0014130
Description
4. Eye disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0015397
Description
5. Gastrointestinal disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0017178
Description
6. Hepatobiliary disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0267792
Description
7. Immune system disorders
Data type
integer
Alias
- UMLS CUI [1]
- C1334156
Description
8. Metabolism and nutrition disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0851358
Description
9. Musculoskeletal and connective tissue disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0263660
Description
10. Neoplasms benign, malignant and unspecified (including cysts and polyps)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1882062
- UMLS CUI [1,2]
- C0205183
- UMLS CUI [2]
- C0006826
- UMLS CUI [3,1]
- C1882062
- UMLS CUI [3,2]
- C0205370
- UMLS CUI [4]
- C0010709
- UMLS CUI [5]
- C0032584
Description
11. Nervous system disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0027765
Description
12. Psychiatric disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0004936
Description
13. Renal and urinary disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0042075
Description
14. Reproductive system and breast disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0851366
Description
15. Respiratory, thoracic and mediastinal disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0851355
Description
16. Skin and subcutaneous tissue disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0178301
Description
17. Vascular disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0042373
Description
18. Infections and infestations
Data type
integer
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0851341
Description
19. Congenital, familial and genetic disorders
Data type
integer
Alias
- UMLS CUI [1]
- C0851352
Description
20. General disorders and administration site conditions
Data type
integer
Alias
- UMLS CUI [1]
- C0851362
Description
21. Injury, poisoning and procedural complications
Data type
integer
Alias
- UMLS CUI [1]
- C0947733
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Screening - Demography; Vital Signs; Cardiovascular medical Conditions; Cardiovascular surgical Procedures; Medical Conditions
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