Trial record 1 of 1 for: NCT01854918

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Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia (OSLER-2)

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ClinicalTrials.gov Identifier: NCT01854918

Recruitment Status : Completed

First Posted : May 16, 2013

Results First Posted : June 11, 2019

Last Update Posted : June 11, 2019

Sponsor:

Information provided by (Responsible Party):

Amgen

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemia and Mixed Dyslipidemia	Biological: Evolocumab Drug: Standard of Care	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	3681 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
Actual Study Start Date :	April 23, 2013
Actual Primary Completion Date :	May 31, 2018
Actual Study Completion Date :	May 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Standard of Care Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.	Biological: Evolocumab Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen Other Names: AMG 145 Repatha Drug: Standard of Care Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Experimental: Evolocumab + Standard of Care Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.	Biological: Evolocumab Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen Other Names: AMG 145 Repatha Drug: Standard of Care Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

Percent Change From Baseline in LDL-C at Weeks 48 and 104 [ Time Frame: Baseline of the parent study and weeks 48 amd 104 ]
Change From Baseline in LDL-C at Weeks 48 and 104 [ Time Frame: Baseline of the parent study and weeks 48 amd 104 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854918

Show 363 Study Locations

Sponsors and Collaborators

Amgen

Investigators

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Study Director:	MD	Amgen

Study Documents (Full-Text)

Documents provided by Amgen:

Study Protocol [PDF] April 3, 2015

Statistical Analysis Plan [PDF] November 18, 2013

More Information

Publications of Results:

Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.

Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov - Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22.

Other Publications:

Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.

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Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01854918 History of Changes
Other Study ID Numbers:	20120138 2012-004357-83 ( EudraCT Number )
First Posted:	May 16, 2013 Key Record Dates
Results First Posted:	June 11, 2019
Last Update Posted:	June 11, 2019
Last Verified:	May 2019

Keywords provided by Amgen:


High cholesterol Raised cholesterol Cholesterol Elevated Cholesterol

Additional relevant MeSH terms:

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Dyslipidemias Hyperlipidemias Hyperlipoproteinemias Lipid Metabolism Disorders Metabolic Diseases Evolocumab Antibodies, Monoclonal	Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Immunologic Factors Physiological Effects of Drugs

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