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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: pramipexole IR Drug: ropinirole |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Parallel Assignment, Safety Study |
| 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 |
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2005 |
| Estimated Primary Completion Date: | September 2010 (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:
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
Hide Study Locations| United States, Alabama | |
| 248.538.00007 Boehringer Ingelheim Investigational Site | |
| Birmingham, Alabama, United States | |
| United States, Arkansas | |
| 248.538.00008 Boehringer Ingelheim Investigational Site | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| 248.538.00021 Boehringer Ingelheim Investigational Site | |
| Fountain Valley, California, United States | |
| 248.538.00022 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| United States, Connecticut | |
| 248.538.00001 Boehringer Ingelheim Investigational Site | |
| New Haven, Connecticut, United States | |
| United States, Florida | |
| 248.538.00016 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| 248.538.00002 Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| 248.538.00023 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| 248.538.00009 Boehringer Ingelheim Investigational Site | |
| Augusta, Georgia, United States | |
| 248.538.00013 Boehringer Ingelheim Investigational Site | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| 248.538.00011 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Maryland | |
| 248.538.00005 Boehringer Ingelheim Investigational Site | |
| Baltimore, Maryland, United States | |
| United States, Michigan | |
| 248.538.00014 Boehringer Ingelheim Investigational Site | |
| Southfield, Michigan, United States | |
| United States, New York | |
| 248.538.00010 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| 248.538.00015 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| 248.538.00020 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| United States, North Carolina | |
| 248.538.00012 Boehringer Ingelheim Investigational Site | |
| Charlotte, North Carolina, United States | |
| United States, Pennsylvania | |
| 248.538.00006 Boehringer Ingelheim Investigational Site | |
| Philadelphia, Pennsylvania, United States | |
| United States, Tennessee | |
| 248.538.00004 Boehringer Ingelheim Investigational Site | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| 248.538.00003 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| United States, West Virginia | |
| 248.538.00017 Boehringer Ingelheim Investigational Site | |
| Morgantown, West Virginia, United States | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 248.538 |
| Study First Received: | September 2, 2005 |
| Last Updated: | November 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00144300 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neurotransmitter Agents Ropinirole Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Antiparkinson Agents Central Nervous System Diseases Dopamine Agonists |
Brain Diseases Neurodegenerative Diseases Protective Agents Pramipexol Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |