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

July 15, 2022 updated by: Amgen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

905

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2015
        • Research Site
      • Maroubra, New South Wales, Australia, 2035
        • Research Site
    • Queensland
      • Carina Heights, Queensland, Australia, 4152
        • Research Site
      • Milton, Queensland, Australia, 4064
        • Research Site
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Research Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Research Site
  • Austria
      • Feldkirch, Austria, 6807
        • Research Site
      • Innsbruck, Austria, 6020
        • Research Site
      • Salzburg, Austria, 5020
        • Research Site
      • Wels, Austria, 4600
        • Research Site
  • Belgium
      • 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
        • Research Site
  • Canada
      • Quebec, Canada, G1V 4M6
        • Research Site
    • British Columbia
      • Victoria, British Columbia, Canada, V8T 5G4
        • Research Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
        • Research Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Research Site
      • London, Ontario, Canada, N5W 6A2
        • Research Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Research Site
      • Sudbury, Ontario, Canada, P3C 5K7
        • Research Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Research Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Research Site
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Research Site
  • Czechia
      • Brno, Czechia, 602 00
        • Research Site
      • Brno, Czechia, 625 00
        • Research Site
      • Chomutov, Czechia, 430 02
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Pardubice, Czechia, 530 02
        • Research Site
      • Plzen, Czechia, 305 99
        • Research Site
      • Praha 2, Czechia, 120 00
        • Research Site
      • Praha 4, Czechia, 140 21
        • Research Site
      • Praha 5, Czechia, 150 06
        • Research Site
      • Slany, Czechia, 274 01
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
  • Hungary
      • 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
        • Research Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Research Site
    • Gauteng
      • Lyttelton, Gauteng, South Africa, 0140
        • Research Site
    • KwaZulu-Natal
      • Amanzimtoti, KwaZulu-Natal, South Africa, 4126
        • Research Site
      • Chatsworth, Durban, KwaZulu-Natal, South Africa, 4092
        • Research Site
    • Western Cape
      • 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
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • 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
        • Research Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Research Site
      • Jacksonville, Florida, United States, 32204
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Ponte Vedra, Florida, United States, 32081
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Research Site
      • Atlanta, Georgia, United States, 30342
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Research Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
      • Chevy Chase, Maryland, United States, 20815
        • Research Site
      • Columbia, Maryland, United States, 21045
        • Research Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Research Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Research Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Research Site
    • New York
      • Endwell, New York, United States, 13760
        • Research Site
      • New Windsor, New York, United States, 12553
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Research Site
      • Raleigh, North Carolina, United States, 27612
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Research Site
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cincinnati, Ohio, United States, 45227
        • Research Site
      • Cincinnati, Ohio, United States, 45246
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Research Site
    • Washington
      • Renton, Washington, United States, 98057
        • Research Site
      • Seattle, Washington, United States, 98104
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evolocumab
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
Biological: Evolocumab
Administered by subcutaneous injection once a month
Other Names:
  • Repatha
  • AMG 145
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
Placebo Comparator: Placebo
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
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
Biological: Placebo
Administered by subcutaneous injection once a month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in LDL-C at Week 52
Time Frame: Baseline and Week 52
Cholesterol was measured by means of ultracentrifugation.
Baseline and Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in LDL-C at Week 52
Time Frame: Baseline and Week 52
Cholesterol was measured by means of ultracentrifugation.
Baseline and Week 52
Percentage of Participants With an LDL-C Response at Week 52
Time Frame: Week 52
An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.
Week 52
Percent Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
Cholesterol was measured by means of ultracentrifugation.
Baseline and Week 12
Percent Change From Baseline in Total Cholesterol at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Total Cholesterol at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Apolipoprotein B at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Lipoprotein(a) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Triglycerides at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52
Time Frame: Baseline and Week 52
Cholesterol was measured by means of ultracentrifugation.
Baseline and Week 52
Percent Change From Week 12 to Week 52 in LDL-C
Time Frame: Week 12 and Week 52
Cholesterol was measured by means of ultracentrifugation.
Week 12 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2012

Primary Completion (Actual)

October 14, 2013

Study Completion (Actual)

October 14, 2013

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 15, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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