NCT00144300已完成4 期
A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 21
- 主要终点
- Expert Panel Overall Assessment Following 2 Years on Drug
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mirapex
Active Comparator
Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines
干预措施: Mirapex (Drug)
Requip
Active Comparator
Requip tablets three times daily (TID) dosing according to manufacturer's guidelines
干预措施: Requip (Drug)
结局指标
主要结局
Expert Panel Overall Assessment Following 2 Years on Drug
时间窗: up to 2 years
Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years(Baseline, 2 year)
- Expert Panel Overall Assessment Following 1 Year on Drug(up to 1 years)
- Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years(2 years)
- Hoehn and Yahr Scale at 2 Years(Up to 2 years)
- Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year(1 year)
- Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year(Baseline, 1 year)
- Hoehn and Yahr Scale at Baseline(Baseline)
- Hoehn and Yahr Scale at 1 Year(Up to 1 year)
- Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year(1 year)
- Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years(Baseline, 2 year)
- Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline(Baseline)
- Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year(Baseline, 1 year)
- Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline(Baseline)
- Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years(2 years)
- Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years(2 years)
- Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years(Baseline, 2 year)
- Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline(Baseline)
- Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs(Screen (Baseline) and final visit (24 months))
- Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year(Baseline, 1 year)
- Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year(1 year)
研究者
研究点 (21)
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