Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164
NCT ID: NCT00650104
Last Updated: 2013-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2002-05-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active
Open label medication - Ropinirole CR
Ropinirole XL (formerly CR)
Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day.
Interventions
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Ropinirole XL (formerly CR)
Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day.
Eligibility Criteria
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Inclusion Criteria
* At least 30 years of age
* Diagnosis of idiopathic Parkinson''s disease (Hoehn \& Yahr criteria)
* Completed either Study 167 or Study 164
Exclusion Criteria
* Dizziness or fainting due to orthostatic hypotension on standing
* Significant sleep disorder
* Drug abuse or alcoholism
30 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Oxnard, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
Kansas City, Kansas, United States
GSK Investigational Site
Edison, New Jersey, United States
GSK Investigational Site
Upland, Pennsylvania, United States
GSK Investigational Site
Houston, Texas, United States
Countries
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References
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Hauser RA, Reichmann H, Lew M, Asgharian A, Makumi C, Shulman KJ. Long-term, open-label study of once-daily ropinirole prolonged release in early Parkinson's disease. Int J Neurosci. 2011 May;121(5):246-53. doi: 10.3109/00207454.2010.546538. Epub 2011 Jan 19.
Other Identifiers
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101468/196
Identifier Type: -
Identifier Source: org_study_id
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