EUCTR2004-002090-23-CZ进行中（未招募）不适用
A phase IIa multicentre randomised double-blind, double-dummy study to evaluate the efficacy and safety of K-111 versus Fenofibrate in patients with hyperlipidaemia.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 99
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
- 性别
- All
入选标准
- •1.Provide written informed consent prior to enrolment (any study-specific procedures or investigations).
- •2.Male or female aged between 18 and 75 years.
- •3.Fasting serum TG level of more than or equal to 200 mg/dL (2.26 mmol/L)and less than or equal to 500 mg/dL (5.65 mmol/L).
- •4.Fasting serum LDL-C less than or equal to 190 mg/dL (4.91 mmol/L).
- •5.If a patient has Type II diabetes mellitus with an HbA1c value less than or equal to 9.0%, and is receiving antihyperglycaemic medication, they must have been on a stable dose of either metformin or an alpha glucosidase inhibitor for more than or equal to 3 months prior to screening.
- •6.If female, be of non-childbearing potential, i.e., post-menopausal (defined as >12 months since last menstrual period) or surgically sterilised, or using adequate barrier contraception if of childbearing potential. If male with female partner of child bearing potential, be using adequate barrier contraception.
- •7.Patients who are not treatment naïve must have completed a 6 week wash out from fibrates or a 4-week wash-out period from all other classes of lipid lowering therapy prior to the start of the dietary run-in period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Currently taking lipid lowering medication and are not able to complete a 6-week wash-out for fibrates or a 4 week wash out for other classes of lipid-lowering therapy prior to the start of the dietary run-in period.
- •2.Have Type I diabetes mellitus.
- •3.Have Type II diabetes mellitus treated with sulphonylurea, insulin or glitazones either currently or during the 3-month period prior to screening.
- •4.Has clinical evidence of symptomatic and/or uncontrolled Coronary artery disease. Any cardiovascular interventional/surgical procedures must have been successfully performed more than 12 months prior to enrollment in the study.
- •5.History of malignant disease (excluding treated basal cell carcinoma).
- •6.History of infection with human immunodeficiency virus (HIV) or hepatitis B or C.
- •7.History of alcohol and/or drug abuse.
- •8.Have uncontrolled hypertension (diastolic blood pressure >100 mmHg). Patients who are taking antihypertensive medication will not be excluded provided they are maintained at a stable dose for 3 months prior to screening and the stable dose is maintained throughout the study.
- •9.Have uncontrolled thyroid disease (thyroid dysfunction controlled for at least 6 months prior to screening is permitted).
- •10.Known homozygous familial hypercholesterolaemia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia) or heterozygous familial hyperlipidaemia.
- •11.Patients with active liver disease or hepatic dysfunction as defined by elevations in liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyltransferase (GGT) and alkaline phosphatase (ALP)] >2 x the upper limit of normal (ULN) at any time between Visit 1 (Week 4) and Visit 3 (Week 1).
- •12.Patients with a serum creatinine >180 micro mol/L at any time between Visit 1 (Week 4) and Visit 3 (Week –1)
- •13.Patients who have serious or unstable medical or psychological conditions which, in the opinion of the investigator, would compromise the patient’s safety or successful participation in the study.
- •14.Currently taking medication known as CYP2C9 inhibitors and/or inducers.
- •15.Patients who started hormone replacement therapy (HRT) less than 6 months prior to screening.
- •16.Currently taking other investigational drugs or have taken part in a clinical trial within the previous 30 days prior to screening.
研究者
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