DRKS00000297已完成3 期
Vasoprotection by Atorvastatin in Children and Adolescents with Diabetes Type 1, a 2-Year Pilot Study - ATV-D-03-005G
Zentrum für Kinder- und JugendmedizinUniversitätsklinikum Freiburg0 个研究点目标入组 30 人开始时间: 2010年1月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 10 Years 至 20 Years（—）
- 性别
- All
入选标准
- •Diabetes type 1
- •- LDL-C below 130 mg/dL
- •- Increased IMT above 0.53 mm
- •- Male or female
- •- CPK below 217 I
排除标准
- •- Pregnancy or breastfeeding
- •- Active liver disease or hepatic dysfunction,
- •AST or ALT above 3x the upper limit of normal (ULN)
- •- CPK above 5xULN or above 3xULN with muscle pain, tenderness, or weakness
- •- Severe renal dysfunction, nephrotic syndrome
- •- Known hypersensitivity to HMG-CoA reductase inhibitors
- •- Other significant abnormalities that may compromise the patient`s safety or successful participation in the study
- •- LDL-C below 25 mg/dL and above 130 mg/dL during the study
研究者
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