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

Amgen

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Biological: Evolocumab; Other: Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01439880

2011-001915-29 (EudraCT Number)

20110110

Details and patient eligibility

About

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

Enrollment: 1,324 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,324 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Biological: Evolocumab

Other: Standard of care

Evolocumab + SOC

Experimental group

Description:

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.

Treatment:

Biological: Evolocumab