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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Evolocumab

Standard of care

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring High cholesterol, Raised cholesterol, Cholesterol, Elevated Cholesterol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Evolocumab + SOC

Arm 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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

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

Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52

Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52

Apolipoprotein B Level at Week 24 and Week 52

Total Cholesterol/HDL-C Ratio at Week 24 and Week 52

Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52

Full Information

NCT ID

NCT01439880

First Posted

September 22, 2011

Last Updated

September 8, 2022

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01439880

Brief Title

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

Acronym

OSLER

Official Title

A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 (Evolocumab)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

October 7, 2011 (Actual)

Primary Completion Date

June 20, 2018 (Actual)

Study Completion Date

June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

High cholesterol, Raised cholesterol, Cholesterol, Elevated Cholesterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1324 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Arm Title

Evolocumab + SOC

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Evolocumab

Other Intervention Name(s)

AMG 145, Repatha

Intervention Description

Administered by subcutaneous injection

Intervention Type

Other

Intervention Name(s)

Standard of care

Intervention Description

Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

Time Frame

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.

Secondary Outcome Measure Information:

Title

Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52

Time Frame