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

September 8, 2022 updated by: Amgen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1324

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2015
        • Research Site
      • Maroubra, New South Wales, Australia, 2035
        • Research Site
      • Sydney, New South Wales, Australia, 2022
        • Research Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Research Site
  • Belgium
      • Anthée, Belgium, 5520
        • Research Site
      • Bruxelles, Belgium, 1200
        • Research Site
      • Gozee, Belgium, 6534
        • Research Site
      • Gribomont, Belgium, 6887
        • Research Site
      • Halen, Belgium, 3545
        • Research Site
      • Ham, Belgium, 3945
        • Research Site
      • Linkebeek, Belgium, 1630
        • Research Site
      • Ukkel, Belgium, 1180
        • Research Site
  • Canada
      • Quebec, Canada, G1V 4M6
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1V6
        • Research Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
        • Research Site
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
        • Research Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Research Site
      • London, Ontario, Canada, N5W 6A2
        • Research Site
      • London, Ontario, Canada, N6A 5B7
        • Research Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Sudbury, Ontario, Canada, P3C 5K7
        • Research Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Research Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Research Site
      • Toronto, Ontario, Canada, M8V 3X8
        • Research Site
      • Woodstock, Ontario, Canada, N4S 5P5
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Research Site
      • Gatineau, Quebec, Canada, J8Y 6S9
        • Research Site
      • Granby, Quebec, Canada, J2G 8Z9
        • Research Site
      • Lachine, Quebec, Canada, H8S 2E4
        • Research Site
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Research Site
  • Czechia
      • Brno, Czechia, 625 00
        • Research Site
      • Brno, Czechia, 603 00
        • Research Site
      • Brno, Czechia, 601 77
        • Research Site
      • Olomouc, Czechia, 775 20
        • Research Site
      • Praha 2, Czechia, 120 00
        • Research Site
      • Praha 4, Czechia, 140 21
        • Research Site
      • Slany, Czechia, 274 01
        • Research Site
      • Svitavy, Czechia, 568 25
        • Research Site
      • Usti nad Orlici, Czechia, 562 18
        • Research Site
      • Znojmo, Czechia, 669 02
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
  • Finland
      • Helsinki, Finland, 00290
        • Research Site
      • OYS, Finland, 90029
        • Research Site
  • Germany
      • Berlin, Germany, 13353
        • Research Site
      • Köln, Germany, 50937
        • Research Site
  • Hong Kong
      • New Territories, Hong Kong
        • Research Site
  • Hungary
      • Budapest, Hungary, 1096
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Dunaujvaros, Hungary, 2400
        • Research Site
      • Gyula, Hungary, 5700
        • Research Site
      • Kecskemet, Hungary, 6000
        • Research Site
      • Komarom, Hungary, 2921
        • Research Site
      • Szolnok, Hungary, 5004
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 455-8530
        • Research Site
      • Nagoya-shi, Aichi, Japan, 454-0933
        • Research Site
      • Nagoya-shi, Aichi, Japan, 462-0825
        • Research Site
    • Fukui
      • Fukui-shi, Fukui, Japan, 910-0837
        • Research Site
    • Fukuoka
      • Kasuga-shi, Fukuoka, Japan, 816-0864
        • Research Site
    • Gunma
      • Fujioka-shi, Gunma, Japan, 375-0015
        • Research Site
      • Maebashi-shi, Gunma, Japan, 371-0022
        • Research Site
      • Maebashi-shi, Gunma, Japan, 371-0046
        • Research Site
      • Takasaki-shi, Gunma, Japan, 370-0829
        • Research Site
    • Hyogo
      • Kawanishi-shi, Hyogo, Japan, 666-0125
        • Research Site
      • Kobe-shi, Hyogo, Japan, 657-0068
        • Research Site
    • Ibaraki
      • Hitachi-shi, Ibaraki, Japan, 317-0077
        • Research Site
      • Koga-shi, Ibaraki, Japan, 306-0041
        • Research Site
      • Mito-shi, Ibaraki, Japan, 311-4198
        • Research Site
    • Ishikawa
      • Komatsu-shi, Ishikawa, Japan, 923-8560
        • Research Site
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 760-8557
        • Research Site
    • Kochi
      • Kochi-shi, Kochi, Japan, 781-8555
        • Research Site
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 615-8125
        • Research Site
      • Kyoto-shi, Kyoto, Japan, 613-0911
        • Research Site
    • Nagano
      • Ina-shi, Nagano, Japan, 396-8555
        • Research Site
      • Matsumoto-shi, Nagano, Japan, 390-0848
        • Research Site
      • Suwa-shi, Nagano, Japan, 392-8510
        • Research Site
    • Osaka
      • Ibaraki-shi, Osaka, Japan, 567-0876
        • Research Site
      • Toyonaka-shi, Osaka, Japan, 560-0082
        • Research Site
    • Saitama
      • Hanyu-shi, Saitama, Japan, 348-8505
        • Research Site
      • Sayama-shi, Saitama, Japan, 350-1305
        • Research Site
      • Toda-shi, Saitama, Japan, 335-0023
        • Research Site
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan, 101-0041
        • Research Site
      • Hachioji-shi, Tokyo, Japan, 192-0918
        • Research Site
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Research Site
      • Shinagawa-ku, Tokyo, Japan, 141-0001
        • Research Site
      • Toshima-ku, Tokyo, Japan, 171-0021
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Research Site
      • Hoorn, Netherlands, 1625 HV
        • Research Site
      • Utrecht, Netherlands, 3584 CX
        • Research Site
  • Norway
      • Oslo, Norway, 0373
        • Research Site
  • Singapore
      • Singapore, Singapore, 169609
        • Research Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Research Site
      • Midrand, Gauteng, South Africa, 1685
        • Research Site
    • Western Cape
      • Observatory, Western Cape, South Africa, 7925
        • Research Site
      • Parow, Western Cape, South Africa, 7505
        • Research Site
  • Spain
      • Madrid, Spain, 28040
        • Research Site
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Research Site
    • Aragón
      • Zaragoza, Aragón, Spain, 50009
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08036
        • Research Site
      • Reus, Cataluña, Spain, 43204
        • Research Site
  • Sweden
      • Göteborg, Sweden, 412 63
        • Research Site
      • Lund, Sweden, 222 21
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site
      • Stockholm, Sweden, 111 35
        • Research Site
  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
      • Birmingham, Alabama, United States, 35216
        • Research Site
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
      • Malvern, Arkansas, United States, 72104
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Carmichael, California, United States, 95608
        • Research Site
      • Inglewood, California, United States, 90301
        • Research Site
      • Mission Viejo, California, United States, 92691
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • Thousand Oaks, California, United States, 91360
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Research Site
      • Littleton, Colorado, United States, 80120
        • Research Site
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Research Site
      • DeLand, Florida, United States, 32720
        • Research Site
      • Green Cove Springs, Florida, United States, 32043
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Jacksonville, Florida, United States, 32223
        • Research Site
      • Melbourne, Florida, United States, 32901
        • Research Site
      • Miami, Florida, United States, 33173
        • Research Site
      • Miami, Florida, United States, 33144
        • Research Site
      • Ponte Vedra, Florida, United States, 32081
        • Research Site
      • Port Charlotte, Florida, United States, 33952
        • Research Site
      • Sanford, Florida, United States, 32771
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Research Site
      • Munster, Indiana, United States, 46321
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Research Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Research Site
      • Portland, Maine, United States, 04101
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
      • Chevy Chase, Maryland, United States, 20815
        • Research Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Research Site
    • Michigan
      • Marquette, Michigan, United States, 49855
        • Research Site
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Research Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Research Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Research Site
      • Las Vegas, Nevada, United States, 89148
        • Research Site
      • Las Vegas, Nevada, United States, 89117
        • Research Site
    • New York
      • Cortlandt Manor, New York, United States, 10567
        • Research Site
      • Endwell, New York, United States, 13760
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
      • Williamsville, New York, United States, 14221
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Research Site
      • Raleigh, North Carolina, United States, 27612
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Research Site
      • Cadiz, Ohio, United States, 43907
        • Research Site
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cincinnati, Ohio, United States, 45227
        • Research Site
      • Cincinnati, Ohio, United States, 45246
        • Research Site
      • Cleveland, Ohio, United States, 44122
        • Research Site
      • Dayton, Ohio, United States, 45414
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73103
        • Research Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Research Site
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15216
        • Research Site
      • York, Pennsylvania, United States, 17405
        • Research Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site
      • Rapid City, South Dakota, United States, 57701
        • Research Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Research Site
    • Texas
      • Arlington, Texas, United States, 76018
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States, 77002
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Research Site
      • Richmond, Virginia, United States, 23294
        • Research Site
    • Washington
      • Renton, Washington, United States, 98057
        • Research Site
      • Seattle, Washington, United States, 98122
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product [all-IP] period.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Other: Standard of care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Experimental: Evolocumab + SOC
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.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Time Frame
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
Baseline of parent study and extension study weeks 24 and 52
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
Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B Level at Week 24 and Week 52
Time Frame: Baseline of parent study and extension study weeks 24 and 52
Baseline of parent study and extension study weeks 24 and 52
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52
Time Frame: Baseline of parent study and extension study weeks 24 and 52
Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52
Time Frame: Baseline of parent study and extension study weeks 24 and 52
Baseline of parent study and extension study weeks 24 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2011

Primary Completion (Actual)

June 20, 2018

Study Completion (Actual)

June 20, 2018

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (Estimate)

September 23, 2011

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110110
  • 2011-001915-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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