Open Label Study of Long Term Evaluation Against LDL-C Trial-2 (OSLER-2)
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01854918
First received: May 1, 2013
Last updated: October 1, 2015
Last verified: September 2015
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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:
MedlinePlus related topics:
Cholesterol
Drug Information available for:
Evolocumab
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Subject incidence of adverse events [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Percent change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ] [ Designated as safety issue: No ]
- Change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ] [ Designated as safety issue: No ]
| Enrollment: | 3681 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | August 2018 |
| Estimated Primary Completion Date: | August 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: evolocumab (AMG 145) and standard of care
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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01854918
Show 363 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854918
Show 363 Study Locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01854918 History of Changes |
| Other Study ID Numbers: | 20120138 |
| Study First Received: | May 1, 2013 |
| Last Updated: | October 1, 2015 |
| 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:
|
Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on September 23, 2016