Description:

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Keywords:
Versions (2) ▾
  1. 11/20/19
  2. 1/9/20
Copyright Holder:
GlaxoSmithKline
Uploaded on:

November 20, 2019

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0
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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease

Screening - Consent Demographics; Central Laboratory; Dermatological Neurological Exam; ECG

Administrative
Informed Consent
Demography
Sex
Final menses - Complete Date Unknown
Became sterile - Complete Date Unknown
Method of contraception
Ethnicity
Geographic Ancestry
Central Laboratory
Laboratory Test
Laboratory Test not done
Central Laboratory - Possible Liver Events
Was there a protocol defined Liver Chemistry Event for the lab samples collected at this visit?
Dermatological Exam
Dermatological Exam not done
Upon examination, were any abnormalities present?
Was subject referred to dermatologist?
Neurological Exam
Neurological examination not done
Neurological Exam
Neurological Test
Neurological abnormalities
Neurological Exam - Intensity/ Abnormal
Was the neurological examination consistent with the diagnosis of Parkinson's disease?
12 Lead Electrocardiogram
Was ECG Performed?
beats/min
ms
ms
ms
Method of QTc Calculation
ms
RR interval not available
QTcB (Bazett)
ms
QTcF (Fridericia)
ms
QTc Interval, other method of correction
Is this a repeat ECG?
Specify reason ECG repeated
Result of the ECG
Rhythm
P-Wave Morphology
Conduction
Myocardial Infarction
Depolarisation/Repolarisation (QRS-T)
Other ECG abnormalities