A 52 WEEK, PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF PF-04950615 IN SUBJECTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - 9002/0157 (B1481021)

Pfizer0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Pfizer
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator*s study team before subjects are included in the study.;Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:;1.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.;2.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.;3.Males and females >=18 years of age.;4.With previously diagnosed HeFH phenotype as defined according to the Simon Broome criteria, described in Appendix 2 or a genetic diagnosis of HeFH.;5.Subjects are required to be treated with atorvastatin, simvastatin, or rosuvastatin at the highest locally approved dose. If at a lower dose, there must be documentation that the subject is receiving a maximally tolerated dose of the aforementioned statins; and no dose should be lower than atorvastatin 20 mg, rosuvastatin 20 mg, or simvastatin 40 mg.;•Subjects on simvastatin 80 mg must have been on this dose for >1 year before screening.;•All subjects must be on a stable dose at least 6 weeks prior to screening. There should be no plans at the time of screening and randomization to modify the dose of statin for the duration of the trial.;•Source records and case report form (CRF) must show documentation of the requirements shown above.;6. Subjects without known history of CVD or diabetes or chronic kidney disease (definition below) who are on the highest approved statin dose must have a LDL-C >=100 mg/dL (2.59 mmol/L)( or LDL-C >= 110 mg/dL [2.84 mmol/L]if at the maximally tolerated statin dose).
•Subjects with known history of CVD or diabetes or CKD (definition below) who are on the highest approved statin dose must have a LDL-C >= 70 mg/dL (1.81 mmol/L) dose ( or >= 77 mg [1.99 mmol/L] if at the maximally tolerated statin dose.)
•Detailed criteria:
•Subjects must meet the following fasting LCL-C minimum levels based on their history of CVD or risk equivalent and statin dose.
•*LDL-C must meet these values at both screening visits and the value at the second screening visit within 7 days of randomization 1 must not be lower or higher than 20% of this initial value, as described in Section 7.1. If the fasting LDL-C at the second screening visit is lower or higher
•than 20% of the initial value, LDL-C can be repeated once (within 7 days of randomization), and the subject is eligible if the value of this repeat test is within 20% (inclusive) of the value for the second screening visit.
•Subjects must also have fasting TG <= 400 mg/dL (4.5 mmol/L) at the second screening visit.
•Known history of CVD or risk equivalent is based on any one of the below:
•Coronary heart disease (any of the following conditions): history of acute myocardial infarction, or evidence of silent myocardial infarction or myocardial ischemia, or history of unstable angina and stable angina pectoris, and or history of coronary procedures (coronary angioplasty
•orand coronary artery surgery);
•Other clinical atherosclerotic diseases (any one of the following conditions): peripheral arterial disease, or abdominal aortic aneurysm, or carotid artery disease (symptomatic [eg, transient ischemic attack or stroke of carotid origin] or >50 percent stenosis on angiography or u

排除标准

•Subjects presenting with any of the following will not be included in the study:;1. 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. Participation in other studies involving small molecule investigational drug(s) (Phases 1-4) within 1 month or 5 half-lives except for cholesteryl ester transfer protein (CETP) inhibitors (indefinitely), or biological agents within 6 months or 5 half lives, whichever is longer before the current study begins and/or during study participation (the investigator should refer to documents provided by the subject on the other study to determine the investigational product half life). If the blind has been broken and the Investigator knows (with documentation) that the subject received placebo, he/she can be included.;3. Subjects with prior exposure to PF-04950615 (RN316) or other investigational PCSK9 inhibitors.;4. Subjects who are unable to receive injections, as either a self-injection, or administered by a family member, health care assistant or health care provider.;5. History of a cardiovascular or erebrovascular event or procedure (eg, Myocardial infarction, stroke, transient ischemic attack, angioplasty) during the past 30 days.;6. Congestive heart failure, New York Heart Association (NYHA) functional class IV, or;Left Ventricular Ejection Fraction measured by imaging < 25%.;7. Poorly controlled hypertension at any screening visit or at randomization (defined as the average of two systolic blood pressure measurements greater than 160 mm Hg or the average of two diastolic blood pressure measurements greater than 100 mm Hg, even with treatment). Subjects who have hypertension and are controlled on stable dosages of anti hypertensive medications can be included. Additional blood pressure (BP) may be performed within the hour or at the completion of the office visit, to confirm a reading.;8. Any history of hemorrhagic stroke or lacunar infarct.;9. Current untreated hypothyroidism or thyroid stimulating hormone (TSH) > 1X Upper Limit of Normal (ULN) at screening. Subjects who are treated and well controlled should be on a stable dose of thyroid hormone for at least 6 months.;10. Current history of alcoholism or drug addiction according to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria within 12 months prior to screening. Use of any recreational drugs within 12 months prior to screening.;11. History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer resolved by excision).;12. Medical history of positive testing for Human Immunodeficiency Virus (HIV).;13. Any disease or condition that might compromise the hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or gastrointestinal systems (unless deemed not clinically significant by the Investigator and/or the Sponsor) or confound the interpretation of the study results. Examples of such conditions include but are not limited to nephrotic syndrome, uncontrolled diabetes, excessive alcohol consumption and cholestatic liver disease. ;14. Use of statins other than atorvastatin, rosuvastatin, simvastatin or use of red yeast rice.;15. Undergoing apheresis or have planned to start apheresis. 16. Initiation of, or change in, non lipid lowering prescription

研究者

发起方

Pfizer

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