摘要
目的通过对烟酸(维生素PP,周围血管扩张药)/洛伐他汀(调血脂药)复方缓释片的3种临床试验方案的讨论,提高II期临床试验的质量水平。方法根据国内外临床试验,拟定出3种临床试验方案。结果用烟酸/洛伐他汀复方缓释整体剂量滴定法在II期临床试验中较为合理。结论在进行烟酸/洛伐他汀复方缓释整体剂量滴定法的II期临床试验中,控制其病例脱落率较为重要。
Objective To develop the level of clinical thrial phase Ⅱ design by discussion the 3 kinds of design of niacin /lovastatine compound extended rellease tablet. Methods The 3 kinds of clinical trial phase II were designed base on the domestic and imported clinical trial. Results It was suitable that whole dosage forced titration of 3 groups of niacin/lovastatine compound extended rellease tablet group, lovastatine tablet group and niacin extended rellease tablet group was used in the clinical trial phase Ⅱ. Conclusion It is imported that the deciduous rate in the clinical trial phase Ⅱ was controlled.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2007年第1期50-53,共4页
The Chinese Journal of Clinical Pharmacology
关键词
烟酸/洛伐他汀复方缓释片
Ⅱ期临床试验方案
niacin/lovastatine compound extended rellease tablet
clinical trial phase Ⅱ design
