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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
Hide Study Locations| United States, Alabama | |
| GSK Investigational Site | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| GSK Investigational Site | |
| San Francisco, California, United States, 94109 | |
| GSK Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Englewood, Colorado, United States, 80110 | |
| United States, Florida | |
| GSK Investigational Site | |
| Boca Raton, Florida, United States, 33486 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33606 | |
| GSK Investigational Site | |
| Panama City, Florida, United States, 32405 | |
| GSK Investigational Site | |
| St. Petersburg, Florida, United States, 33701 | |
| GSK Investigational Site | |
| Port Orange, Florida, United States, 32127 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Augusta, Georgia, United States, 30912 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Glenview, Illinois, United States, 60025 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| GSK Investigational Site | |
| Southfield, Michigan, United States, 48034 | |
| GSK Investigational Site | |
| Traverse City, Michigan, United States, 49684 | |
| GSK Investigational Site | |
| Bingham Farms, Michigan, United States, 48025 | |
| United States, New York | |
| GSK Investigational Site | |
| Albany, New York, United States, 12205 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Toledo, Ohio, United States, 43614-5809 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| GSK Investigational Site | |
| Upland, Pennsylvania, United States, 19013 | |
| United States, Texas | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| Wichita Falls, Texas, United States, 76301 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Milwaukee, Wisconsin, United States, 53233 | |
| Belgium | |
| GSK Investigational Site | |
| Leuven, Belgium, 3000 | |
| GSK Investigational Site | |
| Bruxelles, Belgium, 1200 | |
| GSK Investigational Site | |
| Hoboken, Belgium, 2660 | |
| GSK Investigational Site | |
| Roeselare, Belgium, 8800 | |
| GSK Investigational Site | |
| Hasselt, Belgium, 3500 | |
| Czech Republic | |
| GSK Investigational Site | |
| Ostrava, Czech Republic, 703 52 | |
| GSK Investigational Site | |
| Brno, Czech Republic, 656 91 | |
| GSK Investigational Site | |
| Praha 2, Czech Republic, 120 00 | |
| GSK Investigational Site | |
| Plzen - Lochotin, Czech Republic, 304 60 | |
| GSK Investigational Site | |
| Ostrava 10, Czech Republic, 710 00 | |
| GSK Investigational Site | |
| Pardubice, Czech Republic, 535 03 | |
| GSK Investigational Site | |
| Hradec Kralove, Czech Republic, 500 05 | |
| GSK Investigational Site | |
| Prague, Czech Republic, 100 34 | |
| France | |
| GSK Investigational Site | |
| Rouffach, France, 68250 | |
| GSK Investigational Site | |
| Aix en Provence, France, 13616 | |
| GSK Investigational Site | |
| Lille Cedex, France, 59037 | |
| Hungary | |
| GSK Investigational Site | |
| Budapest, Hungary, 1135 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1083 | |
| GSK Investigational Site | |
| Pécs, Hungary, 7623 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1145 | |
| GSK Investigational Site | |
| Vasvari Pal street 2, H=9023 Gyor, Hungary | |
| GSK Investigational Site | |
| Budapest, Hungary, 1204 | |
| GSK Investigational Site | |
| Debrecen, Hungary, H-4012 | |
| GSK Investigational Site | |
| Miskolc, Hungary, 3529 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1096 | |
| GSK Investigational Site | |
| Miskolc, Hungary, 3526 | |
| Italy, Abruzzo | |
| GSK Investigational Site | |
| Pescara, Abruzzo, Italy, 65100 | |
| Italy, Molise | |
| GSK Investigational Site | |
| Pozzilli (IS), Molise, Italy, 86077 | |
| Italy, Toscana | |
| GSK Investigational Site | |
| Lido Di Camaiore (LU), Toscana, Italy, 55043 | |
| GSK Investigational Site | |
| Grosseto, Toscana, Italy, 58100 | |
| Italy, Veneto | |
| GSK Investigational Site | |
| Vicenza, Veneto, Italy, 36057 | |
| Poland | |
| GSK Investigational Site | |
| Lublin, Poland, 20-718 | |
| GSK Investigational Site | |
| Lublin, Poland, 20-954 | |
| GSK Investigational Site | |
| Gdansk, Poland, 80-211 | |
| GSK Investigational Site | |
| Katowice, Poland, 40-752 | |
| GSK Investigational Site | |
| Warsaw, Poland, 02-097 | |
| GSK Investigational Site | |
| Leszno, Poland, 64-100 | |
| GSK Investigational Site | |
| Bialystok, Poland, 15-276 | |
| GSK Investigational Site | |
| Torun, Poland, 87-100 | |
| GSK Investigational Site | |
| Warszawa, Poland, 01-337 | |
| GSK Investigational Site | |
| Krakow, Poland, 31-530 | |
| GSK Investigational Site | |
| Ciborz, Poland, 66-212 | |
| GSK Investigational Site | |
| Gdansk, Poland, 80-299 | |
| GSK Investigational Site | |
| Poznan, Poland, 61-285 | |
| Spain | |
| GSK Investigational Site | |
| Barcelona, Spain, 08025 | |
| United Kingdom | |
| GSK Investigational Site | |
| Swansea, United Kingdom, SA6 6NL | |
| United Kingdom, Lanarkshire | |
| GSK Investigational Site | |
| Glasgow, Lanarkshire, United Kingdom, G51 4TF | |
| United Kingdom, Lancashire | |
| GSK Investigational Site | |
| Blackpool, Lancashire, United Kingdom, FY3 8BP | |
| United Kingdom, Northumberland | |
| GSK Investigational Site | |
| Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE | |
| United Kingdom, Surrey | |
| GSK Investigational Site | |
| Chertsey, Surrey, United Kingdom, KT16 0QA | |
| 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 |
|
Parkinson's disease open-label long term safety REQUIP ropinirole IR |
ropinirole CR ropinirole XL safety efficacy |
|
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 |