EUCTR2013-002646-36-GB进行中（未招募）1 期
PHASE 3 MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF BOCOCIZUMAB (PF-04950615), IN REDUCING THE OCCURRENCE 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
- 17,000
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, subjects must be men or women age = the legal age of majority (legal adulthood), in the subject’s country.
- •For 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 visit:
- •- atorvastatin, 40 or 80 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 permitted:
- •- 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 lowest available dose, for at least one of those highly effective statins. Intolerance to any statin must be documented as historical adverse events attributed to the statin in question, in the source documentation and CRF.
- •- No background statin therapy
- •Subjects may be enrolled who are only on non-statin lipid lowering therapy, if complete statin intolerance has been documented. Subjects with complete statin intolerance must be unable to tolerate at least two statins: one statin at the
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 study.
- •5. Childbearing potential and/or breast feeding
- •Pregnant females; breastfeeding females; and male and female subjects who (with their partners) are 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 product (refer to Section 4.4.2).
- •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 randomization, defined as the average of two systolic blood pressure (BP) measurements > 180 mmHg or the average of two diastolic BP measurements > 110 mmHg even with treatment. Subjects who have hypertension and are controlled on stable doses of anti-hypertensive medications may be included. An additional BP measurement may be performed within the hour or at the completion of the office visit, to confirm a reading.
- •12. Cerebral hemorrhage risk
- •A prior history of hemorrhagic stroke or lacunar infarct.
- •13. Blood donation
- •Plans to donate blo
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