Clinical effects of Sublingually Administered Rosuvastatin in subjects who are Statin Intolerant - SARSI -001

Dr Gregory Szto0 个研究点目标入组 20 人开始时间: 2016年11月9日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Has suffered side effects attributable to the statin including myalgia, abnormal liver function tests, and/or memory problems.
•Has stopped taking statins more than 1 month prior to enrolment
•Has existing total cholesterol of > 5.5 mmol/L
•Has a history of cardiovascular ischaemic heart disease and is not yet at target levels TC< 4.0mmol/L

•1.Has uncontrolled diabetes, defined by a HbA1c > 9% as measured at visit 1
•2.Has alanine aminotransferase (ALT) > 1.5 times ULN as measured at visit 1
•3.Has aspartate aminotransferase (AST) > 1.5 times ULN as measured at visit 1
•4.Has creatine kinase (CK) > 1.5 times ULN as measured at visit 1
•5.Has triglycerides (TG) > 4.5 mmol/L as measured at visit 1
•6.Has evidence of renal impairment with a serum creatinine of > 200 µmol/L as measured at visit 1
•7.Has known drug or alcohol dependency within 6 months of visit 1
•8.A woman receiving hormonal therapy, including hormone replacement, any oestrogen agonist/antagonist, or oral contraceptives
•9.A woman of childbearing potential not using a an acceptable method of birth control (e.g. hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide)
•10.Woman who is pregnant or breast feeding
•11.Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.

发起方

Dr Gregory Szto