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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01516879
First received: January 18, 2012
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Hypercholesterolemia
 Drug: AMG 145
Other: Placebo
 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 on LDL-C in Hyperlipidemic Subjects

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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: 905
Study Start Date: January 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 145
AMG 145
 Drug: AMG 145
Subjects randomized to the AMG 145 arm will receive AMG 145 subcutaneously every 4 weeks
Placebo Comparator: Placebo
Placebo
 Other: Placebo
Subjects randomized to the placebo arm will receive Placebo subcutaneously every 4 weeks

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516879

  Hide Study Locations
Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States, 35216
United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72205
United States, California
Research Site
Anaheim, California, United States, 92801
Research Site
Encinitas, California, United States, 92024
Research Site
Spring Valley, California, United States, 91978
Research Site
Westlake Village, California, United States, 91361
United States, Florida
Research Site
DeLand, Florida, United States, 32720
Research Site
Jacksonville, Florida, United States, 32216
Research Site
Jacksonville, Florida, United States, 32204
Research Site
Ponte Vedra, Florida, United States, 32081
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30338
Research Site
Atlanta, Georgia, United States, 30342
Research Site
Savannah, Georgia, United States, 31406
United States, Illinois
Research Site
Chicago, Illinois, United States, 60610
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40213
United States, Maine
Research Site
Auburn, Maine, United States, 04210
United States, Maryland
Research Site
Bethesda, Maryland, United States, 20817
Research Site
Chevy Chase, Maryland, United States, 20815
Research Site
Columbia, Maryland, United States, 21045
United States, Massachusetts
Research Site
Brockton, Massachusetts, United States, 02301
United States, Minnesota
Research Site
St. Paul, Minnesota, United States, 55114
United States, Mississippi
Research Site
Olive Branch, Mississippi, United States, 38654
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89148
United States, New York
Research Site
Endwell, New York, United States, 13760
Research Site
New Windsor, New York, United States, 12553
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27612
Research Site
Raleigh, North Carolina, United States, 27609
United States, North Dakota
Research Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Research Site
Akron, Ohio, United States, 44311
Research Site
Cincinnati, Ohio, United States, 45227
Research Site
Cincinnati, Ohio, United States, 45219
Research Site
Cincinnati, Ohio, United States, 45246
United States, Oklahoma
Research Site
Norman, Oklahoma, United States, 73069
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Research Site
Mt. Pleasant, South Carolina, United States, 29464
United States, South Dakota
Research Site
Rapid City, South Dakota, United States, 57702
United States, Texas
Research Site
Houston, Texas, United States, 77030
United States, Virginia
Research Site
Richmond, Virginia, United States, 23294
United States, Washington
Research Site
Renton, Washington, United States, 98057
Research Site
Seattle, Washington, United States, 98104
Australia, New South Wales
Research Site
Camperdown, New South Wales, Australia, 2015
Research Site
Maroubra, New South Wales, Australia, 2035
Australia, Queensland
Research Site
Carina Heights, Queensland, Australia, 4152
Research Site
Milton, Queensland, Australia, 4064
Australia, Victoria
Research Site
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Research Site
Perth, Western Australia, Australia, 6000
Austria
Research Site
Feldkirch, Austria, 6807
Research Site
Innsbruck, Austria, 6020
Research Site
Salzburg, Austria, 5020
Research Site
Wels, Austria, 4600
Belgium
Research Site
Anthée, Belgium, 5520
Research Site
Bruxelles, Belgium, 1200
Research Site
Gent, Belgium, 9000
Research Site
Gozee, Belgium, 6534
Research Site
Ham, Belgium, 3945
Research Site
Oostende, Belgium, 8400
Canada, British Columbia
Research Site
Victoria, British Columbia, Canada, V8T 5G4
Canada, Newfoundland and Labrador
Research Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Canada, Ontario
Research Site
Cambridge, Ontario, Canada, N1R 6V6
Research Site
London, Ontario, Canada, N5W 6A2
Research Site
Newmarket, Ontario, Canada, L3Y 5G8
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Sudbury, Ontario, Canada, P3C 5K7
Research Site
Toronto, Ontario, Canada, M9W 4L6
Research Site
Toronto, Ontario, Canada, M9V 4B4
Canada, Quebec
Research Site
Pointe-Claire, Quebec, Canada, H9R 3J1
Canada
Research Site
Quebec, Canada, G1V 4M6
Czech Republic
Research Site
Brno, Czech Republic, 625 00
Research Site
Brno, Czech Republic, 602 00
Research Site
Chomutov, Czech Republic, 430 02
Research Site
Hradec Kralove, Czech Republic, 500 05
Research Site
Pardubice, Czech Republic, 530 02
Research Site
Plzen, Czech Republic, 305 99
Research Site
Praha 2, Czech Republic, 120 00
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Praha 4, Czech Republic, 140 21
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Praha 5, Czech Republic, 150 06
Research Site
Slany, Czech Republic, 274 01
Denmark
Research Site
Aalborg, Denmark, 9000
Research Site
Ballerup, Denmark, 2750
Research Site
Vejle, Denmark, 7100
Hungary
Research Site
Baja, Hungary, 6500
Research Site
Budapest, Hungary, 1085
Research Site
Budapest, Hungary, 1115
Research Site
Budapest, Hungary, 1125
Research Site
Komarom, Hungary, 2991
Research Site
Pecs, Hungary, 7624
Research Site
Szeged, Hungary, 6720
Research Site
Zalaegerszeg, Hungary, 8900
South Africa
Research Site
Lyttelton, Gauteng, South Africa, 0140
Research Site
Amanzimtoti, KwaZulu-Natal, South Africa, 4126
Research Site
Chatsworth, Durban, KwaZulu-Natal, South Africa, 4092
Research Site
Observatory, Western Cape, South Africa, 7925
Research Site
Paarl, Western Cape, South Africa, 7646
Research Site
Parow, Western Cape, South Africa, 7505
Research Site
Somerset West, Western Cape, South Africa, 7130
Research Site
Bloemfontein, South Africa, 9301
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01516879     History of Changes
Other Study ID Numbers: 20110109
Study First Received: January 18, 2012
Last Updated: May 9, 2013
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

ClinicalTrials.gov processed this record on June 18, 2013