Open Label Study of Long Term Evaluation Against LDL-C Trial-2 (OSLER-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01854918
First received: May 1, 2013
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Hyperlipidemia and Mixed Dyslipidemia
Biological: evolocumab (AMG 145) and standard of care
Other: Standard of care
Phase 3

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 145-2

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of adverse events [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 3515
Study Start Date: April 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: evolocumab (AMG 145) and standard of care 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 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Complete a qualifying evolocumab (AMG 145) parent study

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: NCT01854918

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 346 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01854918     History of Changes
Other Study ID Numbers: 20120138
Study First Received: May 1, 2013
Last Updated: July 16, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Austria: Agency for Health and Food Safety
Italy: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Taiwan : Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare
China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 23, 2014