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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

  Show 96 Study Locations
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