Skip to main content
OpenTrials
Completed

NCT Number: NCT01439880

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Evolocumab

Biological

Administered by subcutaneous injection

Other names: AMG 145, Repatha

Standard of care

Other

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

Primary outcomes

  1. Number of Participants With Adverse Events

    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.

    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 outcomes

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

    Time frame: Baseline of parent study and extension study weeks 24 and 52

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

    Time frame: Baseline of parent study and extension study weeks 24 and 52

  3. Apolipoprotein B Level at Week 24 and Week 52

    Time frame: Baseline of parent study and extension study weeks 24 and 52

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

    Time frame: Baseline of parent study and extension study weeks 24 and 52

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

    Time frame: Baseline of parent study and extension study weeks 24 and 52

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Acronym: OSLER

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Sep 23, 2011
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.