NCT00632736已完成3 期
An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down titration at the end of treatment/early withdrawal).
- •Subjects must not have a break in medication between completing the feeder study (including the down titration phase for studies 168 and 169) and beginning treatment in study
- •Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant System).
- •Provide written informed consent for this study.
- •Be willing and able to comply with study procedures.
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •Patients with any ongoing clinically significant adverse events at the end of the "feeder" studies.
- •Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma).
- •Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the feeder study (REQUIP study 165, 168 or 169).
- •Subjects with severe dizziness or fainting due to postural hypotension on standing.
- •Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit cytochrome P 450 1A2 (CYP1A2 [e.g. ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol]) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
- •Women who are pregnant or breast-feeding.
- •Use of an investigational drug throughout the treatment period.
研究组 & 干预措施
Ropinirole XL (formerly CR)
Active Comparator
Ropinirole XL (formerly CR)
干预措施: Ropinirole XL (formerly CR) (Drug)
结局指标
主要结局
Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 13 February 2004 through 31 March 2010
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
次要结局
- Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26(Week 4 and Week 26)
研究者
研究点 (1)
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