EUCTR2016-000141-31-GB进行中（未招募）1 期
A SERIES OF RANDOMISED CONTROLLED N-of 1 TRIALS IN PATIENTS WHO HAVE DISCONTINUED OR WISH TO DISCONTINUE STATIN USE DUE TO MUSCLE-RELATED SYMPTOMS TO ASSESS IF ATORVASTATIN TREATMENT CAUSES MORE MUSCLE SYMPTOMS THAN PLACEBO - StatinWISE
ondon School of Hygiene and Tropical Medicine0 个研究点目标入组 200 人开始时间: 2016年6月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Adults (aged 16 and over)
- •Prescribed statin treatment in the last 3 years
- •Stopped OR considering stopping statin treatment due to muscle symptoms
- •Provided fully informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •Any previously documented serum alanine aminotransferase (ALT) levels at or above three times the upper limit of normal;
- •Have persistent, generalised, unexplained muscle pain (whether associated or not with statin use) and have creatinine kinase (CK) levels greater than 5 times the upper limit of normal
- •Should not be using atorvastatin 20mg daily in the opinion of the general practitioner.
研究者
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