Phase 3
Completed N=404
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events
Source: ClinicalTrials.gov NCT01953328 ↗
Enrolled (actual)
404
Serious AEs
1.5%
Results posted
Dec 2015
Primary outcomePrimary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 — 0.27; 3.91; -73.70; -69.98 percent change — p=<0.001
Summary
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 |
0.27; 3.91; -73.70; -69.98; -0.42; -2.67 | <0.001 sig |
| PRIMARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
1.28; 5.29; -73.57; -64.62; 1.39; -3.49 | <0.001 sig |
| SECONDARY Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 |
-14.8; -2.6; -104.1; -88.9; -8.9; -5.7 | <0.001 sig |
| SECONDARY Change From Baseline in LDL-C at Week 12 |
-13.7; -0.4; -104.5; -84.0; -7.7; -6.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 |
0.18; 4.26; -68.48; -61.69; -1.57; -1.79 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 |
1.12; 5.55; -67.81; -58.03; -0.07; -2.38 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 |
-0.32; 0.76; -64.76; -58.47; -4.32; -0.85 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 12 |
0.74; 2.42; -64.83; -54.80; -2.47; -1.89 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 |
-2.49; 1.09; -48.03; -42.34; -4.21; -2.35 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at Week 12 |
-1.70; 2.29; -47.14; -39.06; -3.08; -2.44 | <0.001 sig |
| SECONDARY Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 |
3.77; 3.94; -51.00; -48.71; 1.04; 1.58 | <0.001 sig |
| SECONDARY Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 |
4.73; 4.33; -50.72; -46.62; 1.84; 0.83 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12 |
0.06; 2.79; -66.41; -61.55; -1.92; 1.54 | <0.001 sig |
| SECONDARY Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 |
0.71; 4.08; -67.59; -58.45; -1.15; 0.06 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL |
0.0; 0.0; 98.0; 96.0; 22.4; 15.7 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 |
0.0; 4.2; 98.0; 96.0; 20.4; 20.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 |
5.23; 4.07; -45.97; -45.01; 6.52; -5.62 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12 |
4.35; 7.03; -45.72; -41.74; 10.75; -5.73 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 |
4.69; 4.54; -23.23; -17.41; -2.11; 8.06 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides at Week 12 |
7.84; 4.34; -19.73; -15.63; -3.88; 7.30 | <0.001 sig |
| SECONDARY Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 |
-4.83; -1.57; 7.50; 13.05; -4.03; -3.06 | <0.001 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 |
-4.59; -0.40; 8.88; 14.80; -3.57; -2.36 | <0.001 sig |
| SECONDARY Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 |
2.57; 3.10; -25.29; -19.55; -1.32; 9.96 | <0.001 sig |
| SECONDARY Percent Change From Baseline in VLDL-C at Week 12 |
4.09; 2.92; -24.33; -17.89; -3.03; 9.17 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria: Male or female, Japanese adult, 20-85 years of age; Subjects on stable dose of statin for greater than equal to 4 weeks; Fasting LDL-C greater than equal to 100 mg/dL; Fasting triglycerides less than equal to 400 mg/dL; Subject is at high risk for cardiovascular events. Exclusion Criteria: New York heart Association (NYHA) III or IV - heart failure; Uncontrolled cardiac arrhythmia; Uncontrolled hypertension; Type 1 diabetes, poorly controlled type 2 diabetes; Uncontrolled hypothyroidism or hyperthyroidism
Data sourced from ClinicalTrials.gov (NCT01953328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.