EUCTR2016-003485-11-DK进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients with, or at high risk for, Cardiovascular Disease who are Statin Intolerant.
Esperion Therapeutics Inc.,0 个研究点目标入组 14,000 人开始时间: 2017年3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
- 14,000
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. Provision of signed informed consent prior to any study-specific procedure.
- •2. Patient reported SI due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued resulting in an inability to tolerate:
- •2 or more statins at any dose, or
- •1 statin at any dose and unwilling to attempt a second statin or advised by a physician to not attempt a second statin.
- •Please note that patients currently tolerating very low dose statin therapy (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) are considered to be intolerant to that low dose statin. Patients may continue taking very low dose statin therapy throughout the study provided that it is stable (used for at least 4 weeks prior to screening) and well tolerated.
- •3. Written confirmation by both patient and investigator that the patient is statin intolerant as defined above, aware of the benefit of statin use to reduce the risk of MACE including death, and also aware that many other patients who are unable to tolerate a statin are able to tolerate a different statin or dose.
- •4. Age =18 years or legal age of majority based on regional law, whichever is greater, and =85 years at Week -5 (Visit S1).
- •5. Men and nonpregnant, nonlactating women. Women must be one of the following:
- •Naturally postmenopausal defined as =1 year without menses and:
- •o =55 years, or
- •o <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 an acceptable method(s) of birth control during the study and for 30 days after the end of treatment including:
- •o oral, topical, injectable, or implantable birth control medications,
- •o placement of an intrauterine device with or without hormones,
- •o barrier methods including condom or occlusive cap with spermicidal foam or spermicidal jelly,
- •o vasectomized male partner who is the sole partner for this patient,
- •o true abstinence that is in line with the preferred and usual lifestyle of the patient (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], declaration of abstinence for the duration of the study or withdrawal are not acceptable methods of true abstinence).
- •There are no protocol-specific birth control requirements for men with partners who are able to become pregnant.
- •6. Fasting LDL-C =100 mg/dL (2.6 mmol/L) at Week -5 (Visit S1) while taking stable (4 weeks prior to Visit S1) and optimized background LDL-C-lowering therapies that may include very low dose statin (see definition above), ezetimibe, niacin, bile acid resins, fibrates, and/or proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.
- •7. History of, or at high risk for, CVD including documented evidence of one or more of the following:
- •a. Documented history of CVD (ie, secondary prevention)
- •Coronary artery disease, defined by:
- •o MI (either ST-elevation MI or non-ST-elevation MI) occurring greater than 90 days prior to screening, or
- •o Percutaneous coronary or surgical coronary revascularization, occurring greater than 90 days prior to screening, or
- •o Angiographic stenosis of >50% in a least 1 major coronary artery (native or graft vessel), as documented by selective coronary angiography or computed tomography angiography (CTA), o
排除标准
- •1. Total fasting TG >500 mg/dL (5.6 mmol/L) at Week -5 (Visit S1).
- •2. Renal dysfunction or a glomerulonephropathy defined as either nephritic or nephrotic syndrome, including estimated glomerular filtration rate (eGFR; using central laboratory determined Modification of Diet in Renal Disease [MDRD] formula) <30 mL/min/1.73 m2 at Week -5 (Visit S1).
- •3. Forms of CVD that include any of the following:
- •a. Recent (within 90 days prior to or during screening) acute CVD events including, but not only, transient ischemic attack (TIA), MI, coronary revascularization, peripheral arterial revascularization, ischemic stroke, carotid endarterectomy, carotid stenting.
- •b. Recent (within 90 days of screening) unstable or symptomatic cardiac arrhythmia (including any associated medication changes). Patients with stable well-controlled atrial arrhythmias will be allowed to participate in the study.
- •c. Patients with implantable pacemakers or automatic implantable cardioverter defibrillators may be considered if deemed by the investigator to be stable for greater than 90 days prior to screening,
- •d. New York Heart Association (NYHA) Functional Classification Class IV heart failure,
- •e. Uncontrolled hypertension, defined as mean sitting systolic blood pressure (SBP) =180 mmHg and/or diastolic blood pressure (DBP) =110 mmHg,
- •f. Planned coronary revascularization (patient may rescreen 3 months post-procedure).
- •4. HbA1C =10% at Week -5 (Visit S1).
- •5. Uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) >1.5 × the upper limit of normal (ULN) at Week -5 (Visit S1).
- •6. Liver disease or dysfunction, including:
- •a) Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (HCV-ABVivi) at Week -4 (Visit S2), or
- •b) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) =2.0 × ULN at Week -5 (Visit S1).
- •7. Gastrointestinal conditions or procedures (including weight loss surgery; eg, Lap-Band® or gastric bypass) that may affect drug absorption.
- •8. Hematologic or coagulation disorders or a hemoglobin (Hgb) level <10 g/dL at Week -5 (Visit S1).
- •9. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 years. Nonmetastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed.
- •10. Unexplained creatine kinase (CK) >3 × ULN at Week -5 (Visit S1) (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.
- •11. History within the last 2 years of drug, alcohol, amphetamine and derivatives, or cocaine abuse. Patients with amphetamine derivatives prescribed by and under the care of a health care practitioner can be enrolled after evaluation by the investigator.
- •12. Blood transfusion for any reason within 30 days prior to randomization.
- •13. Use of any experimental or investigational drugs within 30 days prior to screening or 5 half-lives, whichever is longer.
- •14. Randomization into another Phase 3 bempedoic acid clinical study.
- •15. Use of, or a plan to initiate, these prohibited therapies/supplements during the study:
- •Mipomersen (must be stopped at least 6 months prior to Week -5 [Visit S1]), lomitapide or apheresis therapy (must be stopped at least 3 months prior to Week -5 [Visit S1]),
- •Red yeast rice (must be stopped at least 2 weeks prior to Week -5 [Visit S1]),
- •Statins are prohibited at average daily doses of rosuvas
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