| February 9, 2007 |
| October 8, 2009 |
| April 2007 |
| March 2009 (final data collection date for primary outcome measure) |
| AUC, Cmax and tmax in the fed and fasted state up to 24-hour post dose in the Maintenance phase and through concentration (Cmin) and in the fixed titration phase at 24-hour post dose of the last dose of 2, 4, and 8mg dose administration [ Time Frame: 24 Hours ] [ Designated as safety issue: No ] |
| AUC, Cmax and tmax in the fed and fasted state up to 24-hour post dose in the Maintenance phase and through concentration (Cmin) and in the fixed titration phase at 24-hour post dose of the last dose of 2, 4, and 8mg dose administration |
| Complete list of historical versions of study NCT00434304 on ClinicalTrials.gov Archive Site |
- Japanese UPDRS(PartⅠ,Ⅱ,Ⅲ and Ⅳ) [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
- Modified Hoehn & Yahr criteria stages [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
- Proportion of subjects who continuously participated in the study [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
- Clinician's global impression on efficacy [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
- Laboratory tests (haematology, biochemistry and urine) [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
- Electrocardiography (Standard 12-Lead ECG) [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
- Vital signs (blood pressure, pulse rate) [ Time Frame: week 0-52 ] [ Designated as safety issue: No ]
|
| Adverse events and Change from baseline in the Japanese UPDRS motor score in Part III (motor scores) at Week 16 |
| |
| Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD) |
| Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study - <Clinical Pharmacology / Exploratory Study> |
This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients. |
| |
| Phase II |
| Interventional |
| Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study |
| Parkinson's Disease |
| Drug: Ropinirole prolonged release/extended release(PR/XR) |
| |
| |
| |
| Completed |
| 62 |
| March 2009 |
| March 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patients who are diagnosed with PD with severity of the Modified Hoehn & Yahr staging at Stage I to III.
- Age: 20 years or older (at the time of giving informed consent)
- Gender: male and female
- Both inpatient and outpatient status
- Informed consent: Patients who are able to give informed written consent in person (i.e. patients who are capable of giving informed written consent on one's own)
- Limited prior exposure to low or moderate doses of L-dopa (up to 3 months in total) or dopamine agonists (up to 6 months in total) provided treatment is discontinued for a minimum of 4 weeks prior to screening.
Exclusion Criteria:
- Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder).
The seriousness refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992).
|
| Both |
| 20 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Japan |
| |
| NCT00434304 |
| Study Director, GSK |
| ROP106064 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| October 2009 |