EUCTR2013-001517-32-DK进行中（未招募）不适用
A dose finding study to assess the safety and efficacy of K-877 in patients with statin-controlled LDL-C but abnormal lipid levels
Kowa Research Europe0 个研究点目标入组 350 人开始时间: 2013年9月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
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. Able to understand and comply with study procedures and give written informed consent
- •2. Aged =18 years
- •3. Have no clinically significant abnormal findings on medical history, physical examination, vital signs, 12 lead electrocardiogram (ECG), and clinical laboratory profiles of both blood and urine that would impair participation or safety in the trial
- •4. After treatment with stable statin therapy for at least 12 weeks prior to screening, have a screening LDL C of no more than 10 mg/dL above the NCEP ATP III target: (see note 2 below):
- •LDL C <70 or <100 mg/dL for patients with CHD or CHD equivalent
- •LDL C <130 mg/dL for patients with multiple risk factors
- •LDL C <160 mg/dL for patients with 0-1 risk factor
- •Note 1: Any statin approved by the regulatory authority in the respective
- •country is allowed with the exception of pravastatin, lovastatin and
- •fluvastatin
- •Note 2: If LDL-C is greater than 10 mg/dL (0.259 mmol/L) above target,
- •patients are only eligible for the study if they are on the maximum
- •allowable statin dose as per approved SPC in the respective country or on the maximum dose tolerated by the respective patient
- •5. Fasting TG value at screening is =175 mg/dL and =500 mg/dL
- •Note: If the patient fails to meet this criterion at SV 1, a fasting re test of TG will be allowed at a second SV
- •6. HDL C value at screening is =50 mg/dL for men and =55 mg/dL for women
- •7. Women may be enrolled if all 3 of the following criteria are met:
- •They are not pregnant
- •They are not breastfeeding, and
- •They do not plan on becoming pregnant during the study
- •8. Women of childbearing potential must have a negative urine
- •pregnancy test at screening. Women are not considered to be of
- •childbearing potential if they meet 1 of the following criteria as
- •documented by the investigator:
- •? - They have had a hysterectomy or tubal ligation at minimum 1 cycle
- •prior to signing the Informed Consent Form
- •? - They are post-menopausal, defined as >=1 year since their last menstrual period for women >= 55 years of age or >=1 year since their last menstrual period and have a follicle-stimulating hormone (FSH) level in menopausal range (defined as > 40 miU/mL) for women < 55 years of age
- •9. Women of childbearing potential must agree to use an effective
- •method of contraception from screening to the end of the study.
- •Effective methods of contraception are those contraceptive methods
- •with a Pearl index of <1 used consistently and correctly (including
- •implantable contraceptives, injectable contraceptives, oral
- •contraceptives, transdermal contraceptives or intrauterine devices
- •10. Male study participants will be required to use condoms with a
- •spermicide during sexual intercourse from screening to the end of the
- •study, even if their sexual partner is or may be pregnant.
- •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 175
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 175
排除标准
- •1. Patients who require other lipid lowering treatments in addition to study drug (K 877) and statin
- •2. Patients with body mass index =40 kg/m2
- •3. Patients with homozygous familial hypercholesterolaemia (heterozygous is permitted) or familial hypoalphalipoproteinaemia
- •4. Patients with type 1 diabetes mellitus
- •5. Patients with poorly controlled type 2 diabetes mellitus (haemoglobin A1c [HbA1c] >10%)
- •6. Patients who are receiving insulin or insulin analog treatment except for stable basal insulin therapy with a single insulin
- •7. Patients with moderate or severe renal impairment (ie, estimated glomerular filtration rate <50 mL/min/1.73m2) at screening
- •8. Patients with serious liver dysfunction; liver function test values >3 × upper limit of the normal (ULN) of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at any screening visit
- •9. Patients with a creatine kinase (CK) level >3 × ULN at screening
- •10. Patients with hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormalities, eg, persistent increase in serum transaminase), gall bladder disease, or pancreatitis
- •11. Patients with a history of drug or alcohol abuse; allowed amounts are 20 g for women and 30 g for men per day (see Appendix D for details on calculating alcohol use)
- •12. Patients who have a hypersensitivity/intolerance to PPARa agonists or statins, contraindications as per approved statin SPC
- •13. Patients who had MI, artery angioplasty, bypass graft surgery, or severe/unstable angina pectoris within 3 months prior to screening
- •14. Patients who had symptomatic cerebrovascular disease including cerebrovascular haemorrhage, ischaemia, or carotid endarterectomy within 3 months of screening
- •15. Patients with symptomatic heart failure (New York Heart Association class III or IV)
- •16. Patients who have uncontrolled hypertension (seated systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg)
- •17. Patients who have used lipid modifying treatment other than statins 28 days prior to screening
- •18. Patients with a history of chronic active hepatitis B or hepatitis C, or known to be infected with human immunodeficiency virus (HIV) 1 or HIV 2
- •19. Patients with known muscular or neuromuscular disease
- •20. Patients with known active or history (<10 years from previous event) of neoplastic disease (excluding basal cell cancer) or patients who may need to take antineoplastic treatment during the study period
- •21. Patients with uncontrolled hypothyroidism or hyperthyroidism
- •Note: controlled thyroid disease (normal serum thyroid stimulating hormone [TSH] and stable therapy for at least 3 months) is permitted
- •22. Patients who have participated in any other clinical studies within 3 months of screening
- •23. Patients who have experienced a loss of more than 400 mL of blood during the 3 months prior to screening, eg, as a blood donor
- •24. Patients with a clinically relevant abnormal history, physical examination findings, 12 lead ECG, or laboratory values at screening that in the opinion of the investigator could interfere with the objectives of the study or the safety of the patient
- •25. Patient has a high possibility they will not be compliant with the requirements of the protocol
- •26. Patients who have a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
研究者
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