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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: August 28, 2015
Last verified: August 2015

January 18, 2012
August 28, 2015
January 2012
November 2013   (final data collection date for primary outcome measure)
Percent Change From Baseline in LDL-C at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Cholesterol was measured by means of ultracentrifugation.
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
Complete list of historical versions of study NCT01516879 on ClinicalTrials.gov Archive Site
  • Change From Baseline in LDL-C at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Cholesterol was measured by means of ultracentrifugation.
  • Percentage of Participants With an LDL-C Response at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.
  • Percent Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Cholesterol was measured by means of ultracentrifugation.
  • Percent Change From Baseline in Total Cholesterol at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Total Cholesterol at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Lipoprotein(a) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Triglycerides at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Cholesterol was measured by means of ultracentrifugation.
  • Percent Change From Week 12 to Week 52 in LDL-C [ Time Frame: Week 12 and Week 52 ] [ Designated as safety issue: No ]
    Cholesterol was measured by means of ultracentrifugation.
  • 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.

Eligible participants with screening central laboratory low-density lipoprotein cholesterol (LDL-C) values ≥ 75 mg/dL (1.9 mmol/L) were instructed to follow National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP) Therapeutic Lifestyle Changes (TLC) diet and were assigned to 1 of the following 4 background lipid-lowering therapies for a 4-week stabilization period based upon their screening LDL-C and its distance from the individual's required goal as stipulated by their NCEP ATP III risk category:

  1. no drug therapy required - diet alone
  2. low dose drug therapy required - diet plus atorvastatin 10 mg orally (PO) once daily (QD)
  3. high dose drug therapy required - diet plus atorvastatin 80 mg PO QD
  4. maximal drug therapy required - diet plus atorvastatin 80 mg PO QD plus ezetimibe 10 mg PO QD.

If the participant met entry criteria at the end of the lipid stabilization period they were randomized 2:1 to receive evolocumab 420 mg or placebo subcutaneously once a month for 52 weeks in addition to their background therapy.

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
    Administered by subcutaneous injection once a month
    Other Names:
    • AMG 145
    • Repatha
  • Biological: Placebo
    Administered by subcutaneous injection once a month
  • Drug: Atorvastatin
    Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.
  • Drug: Ezetimibe
    Background lipid lowering therapy: ezetimibe 10 mg orally once a day
  • Other: Diet Only
    Diet only, no lipid lowering background drug given
  • Experimental: Evolocumab
    Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
    Interventions:
    • Biological: Evolocumab
    • Drug: Atorvastatin
    • Drug: Ezetimibe
    • Other: Diet Only
  • Placebo Comparator: Placebo
    Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
    Interventions:
    • Biological: Placebo
    • Drug: Atorvastatin
    • Drug: Ezetimibe
    • Other: Diet Only

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
905
November 2013
November 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 coronary heart disease (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:

  • New York Heart Association (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   (Adult, Senior)
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
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
August 2015

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