Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study (DESCARTES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01516879
First received: January 18, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.


Condition Intervention Phase
Hypercholesterolemia
Biological: Evolocumab (AMG 145) + background lipid lowering therapy
Biological: Placebo + background lipid lowering therapy
Drug: Atorvastatin 10 mg
Drug: Atorvastatin 80 mg
Drug: Atorvastatin 80 mg + Ezetimibe 10 mg
Other: Diet Only (no drug)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 (Evolocumab) on LDL-C in Hyperlipidemic Subjects

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percent change from baseline in LDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in LDL-C at week 52


Secondary Outcome Measures:
  • Percent change from baseline in LDL-C at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in LDL-C at week 12

  • Percent change from week 12 in LDL-C at week 52 [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Percent change from week 12 in LDL-C at week 52

  • Absolute change from baseline in LDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Absolute change from baseline in LDL-C at week 52

  • Percent change from baseline in non-HDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in non-HDL-C at week 52

  • Percent change from baseline in ApoB at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in ApoB at week 52

  • Percent change from baseline in the total cholesterol/HDL-C ratio at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in the total cholesterol/HDL-C ratio at week 52

  • Percent change from baseline in ApoB/ApoA1 ratio at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in ApoB/ApoA1 ratio at week 52

  • LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 52

  • Percent change from baseline in TC at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in TC at week 12

  • Percent change from baseline in TC at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in TC at week 52

  • Percent change from baseline in Lp(a) at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in Lp(a) at week 52

  • Percent change from baseline in triglycerides at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in triglycerides at week 52

  • Percent change from baseline in HDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in HDL-C at week 52

  • Percent change from baseline in VLDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in VLDL-C at week 52


Enrollment: 901
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evolocumab (AMG 145)
Evolocumab (AMG 145) 420mg subcutaneous QM.
Biological: Evolocumab (AMG 145) + background lipid lowering therapy
Subjects randomized to the evolocumab (AMG 145) arm will receive evolocumab (AMG 145) 420 mg subcutaneously every 4 weeks plus diet (no drug), atorvastatin 10 mg, atorvastatin 80 mg or combination atorvastatin 80 mg plus exetimibe 10 mg.
Drug: Atorvastatin 10 mg
Background lipid lowering therapy
Drug: Atorvastatin 80 mg
Background lipid lowering therapy
Drug: Atorvastatin 80 mg + Ezetimibe 10 mg
Background lipid lowering therapy
Other: Diet Only (no drug)
Diet only, no lipid lowering background drug given
Placebo Comparator: Placebo
Placebo QM
Biological: Placebo + background lipid lowering therapy
Subjects randomized to the placebo arm will receive Placebo 6 ml subcutaneously every 4 weeks + diet (no drug), atorvastatin 10 mg, atorvastatin 80 mg, or combination atorvastatin 80 mg plus ezetimibe 10 mg.
Drug: Atorvastatin 10 mg
Background lipid lowering therapy
Drug: Atorvastatin 80 mg
Background lipid lowering therapy
Drug: Atorvastatin 80 mg + Ezetimibe 10 mg
Background lipid lowering therapy
Other: Diet Only (no drug)
Diet only, no lipid lowering background drug given

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent.
  • Fasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background lipid-lowering therapy:

    • < 100 mg/dL for subjects with diagnosed CHD or CHD risk equivalent
    • < 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent
    • OR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD
  • Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

  • NYHA II-IV heart failure, or last known left ventricular ejection fraction < 30%
  • Uncontrolled cardiac arrhythmia
  • Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization, type 1 diabetes, newly diagnosed or poorly controlled type 2 diabetes
  • Uncontrolled hypertension
  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: NCT01516879

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United States, Alabama
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Birmingham, Alabama, United States, 35216
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
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Anaheim, California, United States, 92801
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Encinitas, California, United States, 92024
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Westlake Village, California, United States, 91361
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DeLand, Florida, United States, 32720
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Jacksonville, Florida, United States, 32216
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Ponte Vedra, Florida, United States, 32081
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Las Vegas, Nevada, United States, 89148
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Chomutov, Czech Republic, 430 02
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Plzen, Czech Republic, 305 99
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Slany, Czech Republic, 274 01
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Aalborg, Denmark, 9000
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Ballerup, Denmark, 2750
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Vejle, Denmark, 7100
Hungary
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Baja, Hungary, 6500
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Budapest, Hungary, 1085
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Budapest, Hungary, 1115
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Budapest, Hungary, 1125
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Komarom, Hungary, 2991
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Pecs, Hungary, 7624
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Szeged, Hungary, 6720
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Zalaegerszeg, Hungary, 8900
South Africa
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Lyttelton, Gauteng, South Africa, 0140
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Amanzimtoti, KwaZulu-Natal, South Africa, 4126
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Chatsworth, Durban, KwaZulu-Natal, South Africa, 4092
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Observatory, Western Cape, South Africa, 7925
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Paarl, Western Cape, South Africa, 7646
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Parow, Western Cape, South Africa, 7505
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Somerset West, Western Cape, South Africa, 7130
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Bloemfontein, South Africa, 9301
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: NCT01516879     History of Changes
Other Study ID Numbers: 20110109
Study First Received: January 18, 2012
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Canada: Health Canada
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency
South Africa: Medicines Control Council
Hungary: National Institute of Pharmacy
Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014