EUCTR2013-002795-41-SK进行中（未招募）1 期
PHASE 3 MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBOCONTROLLED, PARALLEL GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF BOCOCIZUMAB( PF-04950615), IN REDUCING THEOCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN HIGH RISK SUBJECTS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9,000
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. Informed Consent
- •There must be evidence of personally signed and dated informed consent
- •documents for both the pre-screening and screening visits, indicating
- •that the subject (or a legal representative) has been informed of all pertinent aspects of the study. The pre-screening visit informed consent
- •form will be limited to study activities up until the screening visit. The
- •screening visit informed consent form will cover all aspects of the study.
- •2. Compliance
- •Subjects must be willing and able to comply with scheduled visits,
- •treatment plan, laboratory tests, and other study procedures.
- •For subjects who have had a prior CVD event, or who have a condition of
- •elevated LDL-C without a prior CVD event (heterozygous familial
- •hypercholesterolemia [heFH] or an LDL-C=190 mg/dL [4.9 mmol/L]),
- •subjects must be men or women age= the legal age of majority (legal
- •adulthood), in the subject's country. For other subjects who have not
- •had a prior CVD event, men must be age =50 years and women must be
- •age=60 years.
- •4. Acceptance of administration of investigational product
- •Subjects must be willing and able to self-administer or be administered
- •sub-cutaneous injections of investigational product.
- •5. Requirements for background lipid lowering treatment
- •There should be no plans at the time of screening and randomization to
- •modify the dose of statin for the duration of the trial. Unless the
- •background lipid lowering treatment exceptions described below are
- •met, subjects must be treated with one of the following highly effective
- •statins at the specified daily doses for =6 weeks prior to the screening
- •-atorvastatin, 40 or 80 milligrams (mg) once a day;
- •- rosuvastatin, 20 or 40 mg, once a day;
- •- simvastatin 40 mg, once a day or, if a subject has been on that dose for
- •>1 year, 80 mg, once a day.
- •Combination medications that contain atorvastatin, rosuvastatin, or
- •simvastatin components described at the aforementioned doses will be
- •permitted. Background lipid lowering treatment exceptions
- •The following background lipid lowering treatment exceptions are
- •-Lower doses of statins due to partial statin intolerance
- •Subjects may be on a lower dose of one of the highly effective statins
- •described above if there is documented intolerance to any one of them
- •(atorvastatin, rosuvastatin, or simvastatin) at the aforementioned doses.
- •Intolerance to any dose of any statin must be documented as historical
- •adverse events attributed to the statin in question, in the source
- •documentation and case report form (CRF).
- •- Regulatory limitations
- •Subjects may be on a lower dose of one of the highly effective statins
- •described above if the highest locally approved dose for one of the
- •stated statins is lower than those doses shown above (eg, in Japan,
- •atorvastatin 20 mg, once a day, is the highest locally approved dose).
- •- Alternative statins
- •Subjects may be treated with other statins (pravastatin, fluvastatin,
- •pitavastatin, or lovastatin), different from the highly effective statins
- •listed above, if there is documented intolerance to any two different
- •highly effective statins (atorvastatin, rosuvastatin, simvastatin) at the
- 另有 6 项未显示
排除标准
- •1. Personnel involved in the conduct of the study
- •Subjects who are investigational site staff members directly involved in
- •the conduct of the trial and their family members, site staff members
- •otherwise supervised by the Investigator, or subjects who are Pfizer
- •employees directly involved in the conduct of the trial.
- •2. Exclusionary prior CV events or planned revascularization procedures
- •-A planned coronary (PCI or CABG) or other arterial revascularization;
- •-Myocardial infarction, stroke, or any non-coronary arterial
- •revascularization= 30 days prior to screening;
- •-PCI= 90 days prior to screening.
- •3. Participation in prior clinical research studies
- •Participation in other studies involving small molecule investigational
- •drug(s) (Phases 1-4) within 1 month, or five half-lives, of Visit 1,
- •whichever is longer; any
- •participation in a cholesteryl ester transfer protein (CETP) inhibitor trial
- •for any length of time; or any biological agents within 6 months or 5
- •half-lives, of Visit 1, whichever is longer (the investigator should refer to
- •documents provided by the subject on the other study to determine the
- •investigational product half-life). If the blind of the prior study has been
- •broken and the investigator provides documentation that the subject
- •received placebo, the potential subject can be included, regardless of
- •when participation occurred.
- •4. Other exclusionary conditions
- •Other severe, acute, or chronic medical or psychiatric condition or
- •laboratory abnormality that may increase the risk associated with study
- •participation or investigational product administration or may interfere
- •with the interpretation of study results and, in the judgment of the
- •investigator, would make the subject inappropriate for entry into this
- •5. Childbearing potential and/or breast feeding
- •Pregnant females; breastfeeding females; males and females of
- •childbearing potential who are unwilling or unable to use a highly
- •effective method of contraception as outlined in this protocol for the
- •duration of the study and for 63 days after last dose of investigational
- •6. Latex sensitivity
- •Latex sensitive individuals (due to potential for exposure to natural dry
- •rubber in the prefilled syringe cap of investigational product, during
- •administration).
- •7. Apheresis
- •Undergoing lipid apheresis, within 6 weeks of screening, or planned start
- •of lipid apheresis.
- •8. Severe congestive heart failure
- •Congestive heart failure of New York Heart Association (NYHA) Class IV,
- •or if there is prior documentation of left ventricular ejection fraction
- •(LVEF) of <25%, measured by imaging.
- •9. Dialysis
- •Potential subjects with end stage renal disease on dialysis.
- •10. Chronic renal insufficiency
- •Potential subjects with an eGFR of <30 ml/min/1.73m2 by MDRD
- •formula at Visit 1.11. Hypertension
- •Poorly controlled hypertension at any screening visit or at
- 另有 9 项未显示
研究者
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