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临床试验/NCT01097421
NCT01097421已完成不适用

Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease

Boehringer Ingelheim0 个研究点目标入组 329 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
329
主要终点
Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment

研究概览

简要总结

This is an open-label, prospective post marketing surveillance study to be performed in Sweden. Only data of patients idiopathic PD should be documented, in whom the treating physician plans to initiate a pharmacotherapy with PPX ER independent of this observational study. The questionnaires (Morisky Medication Adherence Measure, patient preference scale, CGI-I, PGI-I) will be used to document routine care in a standardized way and thus ensure high validity of the observational data. As the degree medication adherence of patients is routinely evaluated by their physicians, as is patient preference and possible symptom improvement after initiation of a new therapy, the patient questionnaires will be used to standardise medical routine care and to ensure validity of observational data.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Patient with parkinsons disease

干预措施: Pramipexole Extended Release (Drug)

结局指标

主要结局

Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment

时间窗: 8-12 weeks

Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.

Level of Adherence

时间窗: 8-12 weeks

Points on Morisky scale

次要结局

  • Patient Preference(8-12 weeks)
  • Adverse Events (AE) Considered Related to Observed Medication(8-12 weeks)
  • Pramipexole (PPX) Dose(pre-treatment and after 8-12 weeks)
  • Clinical Global Impressions (CGI)(8-12 weeks)
  • Patients Global Impressions (PGI)(8-12 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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