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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00632736 |
Purpose
To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Ropinirole XL (formerly CR) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169. |
| Estimated Enrollment: | 419 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Contacts and Locations
Show 75 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 101468/248 |
| Study First Received: | March 4, 2008 |
| Last Updated: | May 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00632736 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Belgium: Directorate general for the protection of Public health: Medicines; Hungary: National Institute of Pharmacy; Czech Republic: State Institute for Drug Control; United States: Food and Drug Administration |
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Parkinson's disease open-label long term safety REQUIP ropinirole IR |
ropinirole CR ropinirole XL safety efficacy |
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Neurotransmitter Agents Ropinirole Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Antiparkinson Agents Dopamine Agonists |
Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |