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Study 49 of 19937 for search of: | "Molecular Mechanisms of Pharmacological Action" |
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Descriptive Information Fields | |||||
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Brief Title † | Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients | ||||
Official Title † | A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients | ||||
Brief Summary | To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years. |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Diagnostic, Parallel Assignment, Safety Study | ||||
Primary Outcome Measure † | To determine if there is any difference in the presence of retinal deterioration in Parkinson's disease patients treated with pramipexole versus ropinirole. [ Time Frame: 24 months ] | ||||
Secondary Outcome Measure † | To assess and monitor safety and tolerability of pramipexole versus ropinirole in Parkinson's disease patients and to assess progression of Parkinson's disease over the study period. [ Time Frame: 24 months ] | ||||
Condition † | Parkinson Disease | ||||
Intervention † | Drug: pramipexole IR Drug: ropinirole |
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MEDLINE PMIDs | |||||
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Recruitment Information Fields | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 300 | ||||
Start Date † | January 2005 | ||||
Completion Date | |||||
Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria: Diagnosis and main criteria for inclusion. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Exclusion Criteria: Main criteria for exclusion. The presence of any of the following would make a patient ineligible for enrollment into the study:
23. History of severe eye trauma that might affect the outcome of the study 24. History of psychosis 25. Participation in other investigational drug studies or use of investigational drugs within prior 30 days |
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Gender | Both | ||||
Ages | 30 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00144300 | ||||
Organization ID | 248.538 | ||||
Secondary IDs †† | |||||
Study Sponsor † | Boehringer Ingelheim Pharmaceuticals | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
Verification Date | January 2009 | ||||
First Received Date † | September 2, 2005 | ||||
Last Updated Date | January 27, 2009 |