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Completed

NCT Number: NCT01854918

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

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Key information

Conditions

Hyperlipidemia and Mixed Dyslipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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 (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]).

Exclusion criteria

  • Experienced a treatment-related serious adverse event that led to study drug 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 either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen

Other names: AMG 145, Repatha

Standard of care

Drug

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: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period

    Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, 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. Percent Change From Baseline in LDL-C at Weeks 48 and 104

    Time frame: Baseline of the parent study and weeks 48 amd 104

  2. Change From Baseline in LDL-C at Weeks 48 and 104

    Time frame: Baseline of the parent study and weeks 48 amd 104

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

Acronym: OSLER-2

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 16, 2013
Registry last updated
Jun 11, 2019

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.

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