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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01439880
First received: September 22, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Hypercholesterolemia
Biological: Evolocumab (AMG 145) and standard of care
Other: Standard of care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 (Evolocumab)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of treatment emergent adverse events [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Absolute low density lipoprotein cholesterol (LDL-C) at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute non-high density lipoprotein cholesterol (non-HDL-C) at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute apolipoprotein B (ApoB) at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute Apolipoprotein B (ApoeB)/Apolipoprotein A1 (ApoA1) ratio at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]

Enrollment: 1324
Study Start Date: October 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evolocumab (AMG 145) and standard of care
ASSIGNED TO [1] INTERVENTION(S)
Biological: Evolocumab (AMG 145) and standard of care
Evolocumab (AMG 145) is a fully human monoclonal antibody against PCSK9. Standard of care therapy is per local practice; this could include prescribed therapies and/or dietary/exercise regimes
Active Comparator: Standard of care
Standard of care therapy as per local practice
Other: Standard of care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complete a qualifying evolocumab (AMG 145) parent study protocol

Exclusion Criteria:

  • Experienced a treatment-related serious adverse event that led to 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439880

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United States, Alabama
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Birmingham, Alabama, United States, 35216
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Birmingham, Alabama, United States, 35294
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Tucson, Arizona, United States, 85710
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Sayama-shi, Saitama, Japan, 350-1305
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Toda-shi, Saitama, Japan, 335-0023
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Chiyoda-ku, Tokyo, Japan, 101-0041
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Chuo-ku, Tokyo, Japan, 103-0027
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Hachioji-shi, Tokyo, Japan, 192-0918
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Itabashi-ku, Tokyo, Japan, 173-8610
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Shinagawa-ku, Tokyo, Japan, 141-0001
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Toshima-ku, Tokyo, Japan, 171-0021
Netherlands
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Amsterdam, Netherlands, 1105 AZ
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Hoorn, Netherlands, 1625 HV
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Utrecht, Netherlands, 3584 CX
Norway
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Oslo, Norway, 0373
Singapore
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Singapore, Singapore, 169609
South Africa
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Johannesburg, Gauteng, South Africa, 2193
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Midrand, Gauteng, South Africa, 1685
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Observatory, Western Cape, South Africa, 7925
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Parow, Western Cape, South Africa, 7505
Spain
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Cordoba, Andalucía, Spain, 14004
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Zaragoza, Aragón, Spain, 50009
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Barcelona, Cataluña, Spain, 08036
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Reus, Cataluña, Spain, 43204
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Madrid, Spain, 28040
Sweden
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Göteborg, Sweden, 412 63
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Lund, Sweden, 222 21
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Stockholm, Sweden, 111 35
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Stockholm, Sweden, 141 86
United Kingdom
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London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01439880     History of Changes
Other Study ID Numbers: 20110110
Study First Received: September 22, 2011
Last Updated: July 8, 2014
Health Authority: Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research
Norway: Norwegian Medicines Agency
Singapore: Health Science Authority
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Therapeutic Goods Administration
Belgium: Directorate-General for Medicinal Products
Canada: Health Canada
Czech Republic: Statni ustav pro kontrolu leciv
Denmark: Laegemiddelstyrelsen
Finland: Lääkelaitos
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Japan: Ministry of Health, Labor and Welfare

Keywords provided by Amgen:
High cholesterol
Raised cholesterol
Cholesterol
Elevated Cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 10, 2014