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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00144300 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: Mirapex Drug: Requip |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
| Enrollment: | 246 |
| Study Start Date: | January 2005 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mirapex
Mirapex tablets TID dosing according to manufacturer's guidelines
|
Drug: Mirapex
Standard marketed product dispensed according to manufacturer's guidelines
|
|
Active Comparator: Requip
Requip tablets TID dosing according to manufacturer's guidelines
|
Drug: Requip
Standard marketed product dispensed according to manufacturer's guidelines
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations
Show 21 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00144300 History of Changes |
| Other Study ID Numbers: | 248.538 |
| Study First Received: | September 2, 2005 |
| Results First Received: | September 16, 2011 |
| Last Updated: | November 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Pramipexol Ropinirole Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |