Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
Phase 3
Completed
- Conditions
- Hyperlipidemia
- Interventions
- Registration Number
- NCT01763905
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 307
Inclusion Criteria
- Male or female ≥ 18 to ≤ 80 years of age
- Not on a statin or on a low dose statin with stable dose for at least 4 weeks
- History of intolerance to at least 2 statins
- Subject not at LDL-C goal
- Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.
- Fasting triglycerides ≤ 400 mg/dL
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. 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 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. 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 QM Evolocumab Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets 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. Ezetimibe (QM) Ezetimibe Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in 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 Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L) Weeks 10 and 12 Percent Change From Baseline in Apolipoprotein B at Week 12 Baseline and Week 12 Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12 Baseline and Week 12 Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 Baseline and Week 12 Change From Baseline in LDL-C at Week 12 Baseline and Week 12 Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Percent Change From Baseline in Non-HDL-C at Week 12 Baseline and Week 12 Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12 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 the 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 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 Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol 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 Lipoprotein (a) at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 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 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
Trial Locations
- Locations (1)
Research Site
🇬🇧West Bromwich, United Kingdom
Research Site🇬🇧West Bromwich, United Kingdom