A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin versus Ezetimibe Added-on to Rosuvastatin versus Rosuvastatin Dose Increase in Patients Who are Not Controlled on Rosuvastatin - Odyssey Options II

Regeneron Pharmaceuticals, Inc.0 个研究点目标入组 305 人开始时间: 2012年11月29日最近更新: 2021年8月2日

适应症

试验速览

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•A patient must meet either 1a or 1b to be eligible for inclusion in the study:
•a. Patients with screening (visit 1) LDL-C ?70 mg/dL (1.81 mmol/L) who are not adequately controlled with a 10 mg or 20 mg stable daily dose of rosuvastatin for at least 4 weeks before the screening visit (visit 1), with or without other LMT, excluding EZE. Patients with heFH* or non-FH must also have a history of documented CHD (defined below), or non-CHD CVD (defined below) or diabetes mellitus with target organ damage.
•b. Patients with screening (visit 1) LDL-C ?100 mg/dL (2.59 mmol/L) who are not adequately controlled with a 10 mg or 20 mg stable daily dose of rosuvastatin for at least 4 weeks before the screening visit (visit 1), with or without other LMT (excluding EZE). Patients must also have heFH*, or have non-FH, without CHD or non-CHD CVD, but with a calculated 10-year fatal CVD risk SCORE ?5%, or with moderate CKD, or with diabetes mellitus but no target organ damage.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 45

•LDL-C <70 mg/dL (<1.81 mmol/L) in patients with CVD
•LDL-C <100 mg/dL (<2.59 mmol/L) in patients without CVD, but with other risk factors
•LDL-C >250 mg/dL or TG >400 mg/dL
•Homozygous FH or patients receiving plasmapheresis CV event within 3 months prior to screening
•NYHA Class III or IV heart failure
•History of hemorrhagic stroke
•Uncontrolled endocrine disease known to influence serum lipids
•Any clinically significant abnormality that in the judgment of the investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases, patients with short life expectancy, patients who cannot tolerate subcutaneous injections.
•Use of ezetimibe or red yeast rice products within 4 weeks of screening
•Use of systemic corticosteroids or use of fibrates, other than fenofibrate within 6 weeks of the screening
•eGFR <30 mL/min/1.73m2
•ALT or AST aminotransferase >3 x upper limit of normal (ULN)
•CPK >3 x ULN
•TSH < lower limit of normal (LLN)
•Hypersensitivity to monoclonal antibody therapeutics
•Pregnant or breast-feeding women
•Women of childbearing potential with no effective contraceptive method of birth control

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