Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Placebo to Evolocumab; Biological: Evolocumab; Drug: Placebo to Ezetimibe; Drug: Ezetimibe

• 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

Study Timeline

• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-09
• Study Start: 2013-01-24
• Primary Completion: 2013-11-19
• Study Completion: 2013-11-19
• Disposition First Submitted: 2014-05-02
• Disposition First Submitted QC: 2014-05-02
• Disposition First Posted: 2014-05-20
• Results First Submitted: 2015-09-02
• Results First Submitted QC: 2015-11-18
• Results First Posted: 2015-12-22
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-20

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

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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

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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