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 Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

简要总结

主要结局

次要结局

• Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12(Baseline, Week 12)
• Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52(Week 12, 24, 52)
• Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period(Baseline, Week 24, 52)
• Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12(Baseline, Week 12)
• Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
• Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52(Week 12, 24, 52)
• Plasma Concentration Versus Time Summary of PF-04950615(Week 12, 24, 52)
• Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions(Baseline up to end of study (up to 110 weeks))
• Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period(Baseline up to Week 58)
• Number of Participants Who Changed Concomitant Medication During Extension Period(Week 58 follow-up to Week 110)
• Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period(Baseline, Week 58 (follow up), 71, 84, 97, 110)
• Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period(Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110)