EUCTR2007-003237-16-FR进行中（未招募）1 期
A Pilot study to evaluate the Efficacy and Safety of GFT505 (30 mg) orally administered for 28 days in patients with Frederickson Type IIb Dyslipidemia (Mixed Hyperlipidemia). A double blind, placebo-controlled and randomized study.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GENFIT
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provide written informed consent prior to enrolment
- •2. Male or post-menopausal female (defined as >12 months since last menstrual period and with stable (at least 6 months prior to screening) and continuous Hormonal Replacement Therapy if any – surgical removal of ovaries can be considered as surgical menopause”)
- •3. Aged 18 to 75 years
- •4. Type IIb Frederickson hyperlipidemia inadequately controlled despite Therapeutic Lifestyle Change (TLC) recommendations (diet and exercise)* - *(documented or highly probable at V1)
- •5. Non-hypertensive or patient taking antihypertensive medication maintained at a stable dose for 2 months at least prior to screening (and the stable dose can be maintained throughout the study)
- •6. Fasting TG = 200 mg/dL and = 500 mg/dL (2,28 mmol/L = TG = 5,65 mmol/L) at V2
- •7. Fasting LDL-C = 130 mg/dL and = 220 mg/dL (3,36 mmol/L = LDL-C = 5,69 mmol/L) at V2
- •8. CHD (Coronary Heart Disease) risk lower than 20% at ten years (using Framingham Table) determined using laboratory lipid profile at V2, BP at V2 and medical history collected from the patient
- •9. Patient agrees to come to following visits and it is possible to schedule V4 and V5 inside the protocol specified range (14 days +/- 2 days between V3 and V4 ; 14 days +/- 2 days between V4 and V5)
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Body Mass Index (BMI) = 35 kg/m2
- •2. Known clinical evidence of Coronary Artery Disease prior to or at screening
- •3. Blood Pressure > 160 / 95 mmHg
- •4. Known alcohol and/or any other drug abuse or dependence. Alcohol consumption of more than 21 alcoholic beverages per week is considered abusive. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer
- •5. Type I or Type II diabetes mellitus
- •6. Known homozygous familial hypercholesterolaemia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- •7. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B or C
- •8. Known history of malignant disease (excluding treated basal cell carcinoma)
- •9. Patients who have serious or unstable medical or psychological conditions which, in the opinion of the Investigator, would lead the patient to be non-compliant or uncooperative during the study or would compromise the patient’s safety or successful participation in the study
- •10. Patients who have donated blood or blood products within the previous month prior to screening or who plan to donate blood or blood products at any time during the trial and in the 3 months following the end of the study
- •11. The Patient is a female of childbearing potential, is pregnant or lactating
- •12. Any medication that may interfere with study medication absorption, distribution, metabolism or excretion or could lead to induction or inhibition of microsomial enzymes within 3 months prior to the screening day
- •13. Currently taking other investigational drugs or have taken part in a clinical trial within the previous month prior to screening
- •14. Known intolerance or contra-indication to the list of excipients of GFT505 (Gelatin, Lactose, Glycerol, Titanium dioxide, Red Iron dioxide)
- •15. Patient not covered by Health Insurance System and / or not in compliance with the recommendations of National Law in force
- •16. Patient who cannot be contacted in case of emergency
- •17. Uncontrolled hypothyroidism defined as TSH > 2 x the upper limit of normal (ULN) at V2 (thyroid dysfunction controlled for at least 6 months prior to screening is permitted)
- •18. Significant renal disease, including nephritic syndrome, chronic renal failure and/or serum creatinine >180µmol/L at V2
- •19. 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 V2
- •20. Unexplained serum creatine kinase (CPK) > 3 x the upper limit of normal (ULN) at V2. Patients with a reason for CPK elevation may continue in screening and have the measurement repeated prior to randomization; a repeat CPK > 3 x ULN is exclusionary
- •21. Patient for whom the wash-out period of lipid-regulating drugs (fibrates, statins and other classes of lipid-regulating drugs) has not been respected or who has taken any other drug that is known to affect the lipid metabolism
研究者
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