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

January 18, 2012
July 14, 2014
January 2012
October 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01516879 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • 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.
  • 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
  • Experimental: Evolocumab (AMG 145)
    Evolocumab (AMG 145) 420mg subcutaneous QM.
    Interventions:
    • Biological: Evolocumab (AMG 145) + background lipid lowering therapy
    • Drug: Atorvastatin 10 mg
    • Drug: Atorvastatin 80 mg
    • Drug: Atorvastatin 80 mg + Ezetimibe 10 mg
    • Other: Diet Only (no drug)
  • Placebo Comparator: Placebo
    Placebo QM
    Interventions:
    • 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)
Blom DJ, Hala T, Bolognese M, Lillestol MJ, Toth PD, Burgess L, Ceska R, Roth E, Koren MJ, Ballantyne CM, Monsalvo ML, Tsirtsonis K, Kim JB, Scott R, Wasserman SM, Stein EA; DESCARTES Investigators. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014 May 8;370(19):1809-19. doi: 10.1056/NEJMoa1316222. Epub 2014 Mar 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
901
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Hungary,   South Africa
 
NCT01516879
20110109
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP