Status:
COMPLETED
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who partici...
Eligibility Criteria
Inclusion
- Males or non-pregnant/non-breast feeding females
- At least 30 years of age
- Diagnosis of idiopathic Parkinson''s disease (Hoehn \& Yahr criteria)
- Completed either Study 167 or Study 164
Exclusion
- Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy
- Dizziness or fainting due to orthostatic hypotension on standing
- Significant sleep disorder
- Drug abuse or alcoholism
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00650104
Start Date
May 1 2002
End Date
March 1 2009
Last Update
May 6 2013
Active Locations (10)
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1
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
2
GSK Investigational Site
Los Angeles, California, United States, 90033
3
GSK Investigational Site
Oxnard, California, United States, 93030
4
GSK Investigational Site
Miami, Florida, United States, 33136