January 7, 2013
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January 9, 2013
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August 28, 2015
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December 30, 2015
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December 30, 2015
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January 2013
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October 2013 (Final data collection date for primary outcome measure)
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- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
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Complete list of historical versions of study NCT01763827 on ClinicalTrials.gov Archive Site
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- Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL [ Time Frame: Weeks 10 and 12 ]
- Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 [ Time Frame: Week 12 ]
- Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Non-HDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Lipoprotein (a) at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Triglycerides at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in VLDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in HDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
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- Mean change from baseline in low density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ]
Mean change from baseline in low density lipoprotein-cholesterol
- Change from baseline in low density lipoprotein-cholesterol [ Time Frame: 12 Weeks ]
Change from baseline in low density lipoprotein-cholesterol
- Mean Low Density Lipoprotein-Cholesterol (LDL-C) response (LDL-C < 70 mg/dL [1.8 mmol/L]) [ Time Frame: 10 and 12 Weeks ]
Mean Low Density Lipoprotein-Cholesterol (LDL-C) response (LDL-C < 70 mg/dL [1.8 mmol/L])
- Low Density Lipoprotein-Cholesterol (LDL-C) response (LDL-C < 70 mg/dL [1.8 mmol/L]) [ Time Frame: 12 Weeks ]
Low Density Lipoprotein-Cholesterol (LDL-C) response (LDL-C < 70 mg/dL [1.8 mmol/L])
- Mean percent change from baseline in non-high density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in non-high density lipoprotein-cholesterol
- Percent change from baseline in non-high density lipoprotein-cholesterol [ Time Frame: 12 Weeks ]
Percent change from baseline in non-high density lipoprotein-cholesterol
- Mean percent change from baseline in apolipoprotein B [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in apolipoprotein B
- Percent change from baseline in apolipoprotein B [ Time Frame: 12 Weeks ]
Percent change from baseline in apolipoprotein B
- Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio
- Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: 12 Weeks ]
Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio
- Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
- Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: 12 Weeks ]
Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
- Mean percent change from baseline in lipoprotein (a) [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in lipoprotein (a)
- Percent change from baseline in lipoprotein (a) [ Time Frame: 12 Weeks ]
Percent change from baseline in lipoprotein (a)
- Mean percent change from baseline in triglycerides [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in triglycerides
- Percent change from baseline in triglycerides [ Time Frame: 12 Weeks ]
Percent change from baseline in triglycerides
- Mean percent change from baseline in high density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in high density lipoprotein-cholesterol
- Percent change from baseline in high density lipoprotein-cholesterol [ Time Frame: 12 Weeks ]
Percent change from baseline in high density lipoprotein-cholesterol
- Mean percent change from baseline in very low density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in very low density lipoprotein-cholesterol
- Percent change from baseline in very low density lipoprotein-cholesterol [ Time Frame: 12 Weeks ]
Percent change from baseline in very low density lipoprotein-cholesterol
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Not Provided
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Not Provided
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Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 |
A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or Less |
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. |
Not Provided |
Interventional |
Phase 3 |
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Hyperlipidemia |
- Biological: Evolocumab
Administered by subcutaneous injection
- Drug: Ezetimibe
Administered orally once a day
Other Name: Zetia
- Biological: Placebo to Evolocumab
Administered by subcutaneous injection
- Other: Placebo to Ezetimibe
Administered orally once daily
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- Placebo Comparator: Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
Interventions:
- Biological: Placebo to Evolocumab
- Other: Placebo to Ezetimibe
- Placebo Comparator: Placebo QM
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
Interventions:
- Biological: Placebo to Evolocumab
- Other: Placebo to Ezetimibe
- Active Comparator: Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Interventions:
- Drug: Ezetimibe
- Biological: Placebo to Evolocumab
- Active Comparator: Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Interventions:
- Drug: Ezetimibe
- Biological: Placebo to Evolocumab
- Experimental: Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Interventions:
- Biological: Evolocumab
- Other: Placebo to Ezetimibe
- Experimental: Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Interventions:
- Biological: Evolocumab
- Other: Placebo to Ezetimibe
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Koren MJ, Lundqvist P, Bolognese M, Neutel JM, Monsalvo ML, Yang J, Kim JB, Scott R, Wasserman SM, Bays H; MENDEL-2 Investigators. Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2531-2540. doi: 10.1016/j.jacc.2014.03.018. Epub 2014 Mar 29. |
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Completed |
615 |
600 |
October 2013 |
October 2013 (Final data collection date for primary outcome measure) |
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)
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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Sexes Eligible for Study: |
All |
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18 Years to 80 Years (Adult, Senior) |
No |
Contact information is only displayed when the study is recruiting subjects |
Australia, Belgium, Canada, Denmark, France, Korea, Republic of, South Africa, Taiwan, Turkey, United States |
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NCT01763827 |
20110114 |
Yes |
Not Provided |
Not Provided |
Amgen |
Amgen |
Not Provided |
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Amgen |
November 2015 |