EUCTR2016-004084-39-CZ进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with Elevated LDL-C on Low Dose or Less than Low Dose Statins
Esperion Therapeutics Inc.,0 个研究点目标入组 225 人开始时间: 2017年4月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 225
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
- •Each potential patient must satisfy all inclusion criteria to be enrolled in the study. Selected inclusion criteria are listed below; all inclusion criteria are listed in the protocol body.
- •1. Provision of written informed consent prior to any study-specific procedure
- •2. Age =18 years or legal age of majority based on regional law, whichever is greater, at Week -5 (Visit S1)
- •3. Fasting (minimum of 10 hours) calculated LDL-C at Week -5 (Visit S1) as defined by ezetimibe use at screening:
- •For patients who have been taking ezetimibe 10 mg daily prior to Week -5 (Visit S1): Fasting LDL-C =100 mg/dL (2.6 mmol/L) on stable background lipid-modifying therapy (LMT; greater than or equal to 4 weeks prior to screening).
- •For patients who have not been taking ezetimibe Week -5 (Visit S1): Fasting LDL-C =120 mg/dL (3.1 mmol/L) on stable background LMT (greater than or equal to 4 weeks prior to screening).
- •All patients must have fasting LDL-C =70 mg/dL (1.8 mmol/L) at Week -1 (Visit S3).
- •4. Currently receiving stable (greater than or equal to 4 weeks prior to screening) background statin dose that does not exceed low dose statin therapy.
- •Note: Patients must report attempting greater than low dose statin therapy and being unable to tolerate it due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued or the dose lowered. Low dose statin therapy is defined as
- •an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg,
- •simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.
- •Very low dose statin therapy is defined as an average daily dose of rosuvastatin <5 mg, atorvastatin <10 mg, simvastatin <10 mg,
- •lovastatin <20 mg, pravastatin <40 mg, fluvastatin <40 mg, or
- •pitavastatin <2 mg. Patients on ezetimibe and low or very low dose statin or unable to tolerate any statin at any dose are also eligible.
- •Patients may continue taking low or very low dose statin therapy
- •throughout the study provided that it is stable (greater than or equal to 4 weeks) and well tolerated. Patients unable to take
- •any dose of statins are also eligible provided that statin therapy has been attempted.
- •5. Men and nonpregnant, nonlactating women. Women must be either
- •Naturally postmenopausal defined as =1 year without menses and
- •- =55 years, or
- •- <55 years with follicle-stimulating hormone (FSH) =40.0 IU/L, or
- •Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation, or
- •Women of childbearing potential willing to use 2 acceptable method of birth control (unless they have agreed to follow the definition of true abstinence). The minimal requirement for adequate contraception should be started on Day 1, continuing during the study period and for at least 30 days after the last dose of study drug. Acceptable methods of birth
- •control include:
- •-oral, implantable, injectable, or topical birth control medications
- •- oral, implantable, or topical birth control medications
- •- placement of an intrauterine device with or without hormones
- •- barrier methods including condom or occlusive cap with spermicidal foam or spermicidal jelly
- •- vasectomized male partner who is the sole partner for this patient
- •- True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], declaration of abstinence
排除标准
- •1. BMI >50 kg/m2
- •2. Recent history of documented clinically significant cardiovascular disease including, but not limited to
- •Within 3 months of screening, (Week -5 [Visit S1]) or between
- •screening and randomization, MI, severe/unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, stroke, transient ischemic attack, cerebrovascular event, symptomatic carotid artery disease, or symptomatic peripheral arterial disease
- •Uncontrolled hypertension
- •Within 3 months of screening (Week -5 [Visit S1]) or between
- •screening and randomization visits, an arrhythmia requiring medical intervention
- •Planned revascularization procedures
- •New York Heart Association (NYHA) Class IV heart failure
- •3. Total fasting (minimum of 10 hours) TG =500 mg/dL (5.6 mmol/L) at Week -5 (S1)
- •4. Hemoglobin A1C (HbA1C) =10% at Week -5 (Visit S1)
- •5. Persistent poor adherence with ezetimibe and/or single-blind, placebo study drug or lack of tolerance to run-in medications assessed prior to randomization.
- •6. Uncontrolled hypothyroidism. Patients stabilized on thyroid
- •replacement therapy for at least 6 weeks prior to randomization are allowed
- •7. Liver disease or dysfunction, including:
- •Positive serology for hepatitis B surface antigen (HBsAg) and/or
- •hepatitis C antibodies (HCV-ABVivi) at Week -4 (Visit S2), or
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =2× ULN, and/or total bilirubin (TB) =2 × ULN at Week -2 (Visit S1). If TB=1.2 × ULN, a reflex indirect (unconjugated) bilirubin will be obtained.
- •8. Renal dysfunction or glomerulonephritis, including estimated
- •glomerular filtration rate (eGFR; using central laboratory determined Modification of Diet in Renal Disease [MDRD] formula) <30 mL/min at Week -5 (Visit S1).
- •10. Hematologic or coagulation disorders or a hemoglobin (Hgb) level<10.0 g/dL at Week -5 (Visit S1);
- •11. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 years
- •12. Unexplained creatine kinase (CK) >3 × ULN at any time prior to
- •randomization (ie, not associated with recent trauma or physically strenuous activity). Patients with an explained CK elevation must have single repeat CK =3 × ULN prior to randomization;
- •13. History of drug or alcohol abuse within the last 2 years or reported current consumption of >14 alcoholic drinks/week, or any illicit drug use, history of amphetamine and derivatives abuse or cocaine abuse
- •14. Blood donation, participation in a multiple blood draws, clinical study, major trauma, blood transfusion or surgery with or without blood loss within 30 days prior to randomization
- •15. Use of any experimental or investigational drugs within 30 days prior to screening. Patients who have enrolled in a study of an experimental small interfering RNA (siRNA) inhibitor of PCSK9 are excluded;
- •16. Previous enrollment in a bempedoic acid clinical study.
- •17. Use of any of the following drugs prior to screening (Week -5, Visit S1) or a plan to use these drugs during the study as follows:
- •Within 2 weeks prior to screening
- •- Cholestin or red yeast rice-containing products (also known as
- •monascus purpureus extract)
- •Within 4 weeks prior to screening
- •- Statin doses exceeding those defined as low dose. Doses exceeding low dose statin therapy are defined as an average daily dose of rosuvastatin greater than 5 mg, atorvastatin greater than 10 mg, simvastatin greater than 10 mg, lovastatin greater than 20 mg, pravastatin greater
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