Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
Phase 3
Completed
- Conditions
- Hyperlipidemia
- Interventions
- Registration Number
- NCT01763827
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 615
Inclusion Criteria
- Male or female ≥ 18 to ≤ 80 years of age
- National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less
- Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
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Exclusion Criteria
- History of coronary heart disease
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)
- Uncontrolled hypothyroidism or hyperthyroidism
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Q2W Placebo to Evolocumab Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. Placebo Q2W Placebo to Ezetimibe Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. Placebo QM Placebo to Evolocumab Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. Placebo QM Placebo to Ezetimibe Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. Ezetimibe (Q2W) Placebo to Evolocumab Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. Ezetimibe (QM) Placebo to Evolocumab Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. Evolocumab Q2W Evolocumab Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. Evolocumab Q2W Placebo to Ezetimibe Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. Evolocumab QM Evolocumab Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. Evolocumab QM Placebo to Ezetimibe Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. Ezetimibe (QM) Ezetimibe Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. Ezetimibe (Q2W) Ezetimibe Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline and Week 12 Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Percent Change From Baseline in Lipoprotein (a) at Week 12 Baseline and Week 12 Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Change From Baseline in LDL-C at Week 12 Baseline and Week 12 Percent Change From Baseline in Non-HDL-C at Week 12 Baseline and Week 12 Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Percent Change From Baseline in Apolipoprotein B at Week 12 Baseline and Week 12 Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12 Baseline and Week 12 Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 Baseline and Week 12 Percent Change From Baseline in Triglycerides at Week 12 Baseline and Week 12 Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Percent Change From Baseline in VLDL-C at Week 12 Baseline and Week 12 Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Percent Change From Baseline in HDL-C at Week 12 Baseline and Week 12 Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL Weeks 10 and 12 Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 Week 12 Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12
Trial Locations
- Locations (1)
Research Site
🇹🇷Istanbul, Turkey