Open Label Study of Long Term Evaluation Against LDL-C Trial

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Biological: Evolocumab; Other: Standard of care

• Registration Number: NCT01439880
• Lead Sponsor: Amgen

Brief Summary

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Study Start: 2011-10-07
• Primary Completion: 2018-06-20
• Study Completion: 2018-06-20
• Results First Submitted: 2019-06-17
• Results First Submitted QC: 2019-06-17
• Results First Posted: 2019-07-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1324

Inclusion Criteria

• Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)

Exclusion Criteria

• Experienced a treatment-related serious adverse event that led to investigational product (IP) discontinuation in the parent study
• Have an unstable medical condition, in the judgment of the investigator
• Known sensitivity to any of the products to be administered during dosing
• Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evolocumab + SOC	Evolocumab	Participants received evolocumab 420 mg once a month plus standard of care for the first year of the study (SOC-controlled period). At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.
Standard of Care	Evolocumab	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product \[all-IP\] period.
Standard of Care	Standard of care	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product \[all-IP\] period.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.	Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.

Secondary Outcome Measures

Name	Time	Method
Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52	Baseline of parent study and extension study weeks 24 and 52
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52	Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B Level at Week 24 and Week 52	Baseline of parent study and extension study weeks 24 and 52
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52	Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52	Baseline of parent study and extension study weeks 24 and 52

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom