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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Placebo
Atorvastatin
Ezetimibe
Diet Only
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Cholesterol, High Cholesterol, Elevated Cholesterol, Raised Cholesterol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Evolocumab

Placebo

Arm Description

Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in LDL-C at Week 52
Cholesterol was measured by means of ultracentrifugation.

Secondary Outcome Measures

Change From Baseline in LDL-C at Week 52
Cholesterol was measured by means of ultracentrifugation.
Percentage of Participants With an LDL-C Response at Week 52
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
Cholesterol was measured by means of ultracentrifugation.
Percent Change From Baseline in Total Cholesterol at Week 12
Percent Change From Baseline in Total Cholesterol at Week 52
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52
Percent Change From Baseline in Apolipoprotein B at Week 52
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52
Percent Change From Baseline in Lipoprotein(a) at Week 52
Percent Change From Baseline in Triglycerides at Week 52
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52
Cholesterol was measured by means of ultracentrifugation.
Percent Change From Week 12 to Week 52 in LDL-C
Cholesterol was measured by means of ultracentrifugation.

Full Information

First Posted
January 18, 2012
Last Updated
July 15, 2022
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01516879
Brief Title
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
Acronym
DESCARTES
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2012 (Actual)
Primary Completion Date
October 14, 2013 (Actual)
Study Completion Date
October 14, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: no drug therapy required - diet alone low dose drug therapy required - diet plus atorvastatin 10 mg orally (PO) once daily (QD) high dose drug therapy required - diet plus atorvastatin 80 mg PO QD 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Cholesterol, High Cholesterol, Elevated Cholesterol, Raised Cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
905 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evolocumab
Arm Type
Experimental
Arm Description
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Administered by subcutaneous injection once a month
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection once a month
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Intervention Description
Background lipid lowering therapy: ezetimibe 10 mg orally once a day
Intervention Type
Other
Intervention Name(s)
Diet Only
Intervention Description
Diet only, no lipid lowering background drug given
Primary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C at Week 52
Description
Cholesterol was measured by means of ultracentrifugation.
Time Frame
Baseline and Week 52
Secondary Outcome Measure Information:
Title
Change From Baseline in LDL-C at Week 52
Description
Cholesterol was measured by means of ultracentrifugation.
Time Frame
Baseline and Week 52
Title
Percentage of Participants With an LDL-C Response at Week 52
Description
An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.
Time Frame
Week 52
Title
Percent Change From Baseline in LDL-C at Week 12
Description
Cholesterol was measured by means of ultracentrifugation.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Total Cholesterol at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Total Cholesterol at Week 52
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Apolipoprotein B at Week 52
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Lipoprotein(a) at Week 52
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Triglycerides at Week 52
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52
Description
Cholesterol was measured by means of ultracentrifugation.
Time Frame
Baseline and Week 52
Title
Percent Change From Week 12 to Week 52 in LDL-C
Description
Cholesterol was measured by means of ultracentrifugation.
Time Frame
Week 12 and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Research Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Research Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Research Site
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Research Site
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Research Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Research Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Research Site
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Research Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Research Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Research Site
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Research Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Research Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Research Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Research Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Research Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Research Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2015
Country
Australia
Facility Name
Research Site
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Research Site
City
Carina Heights
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
Research Site
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Research Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Research Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Research Site
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Research Site
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Research Site
City
Anthée
ZIP/Postal Code
5520
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Gozee
ZIP/Postal Code
6534
Country
Belgium
Facility Name
Research Site
City
Ham
ZIP/Postal Code
3945
Country
Belgium
Facility Name
Research Site
City
Oostende
ZIP/Postal Code
8400
Country
Belgium
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G4
Country
Canada
Facility Name
Research Site
City
Bay Roberts
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A0A 1G0
Country
Canada
Facility Name
Research Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Research Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Research Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3C 5K7
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Research Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Research Site
City
Chomutov
ZIP/Postal Code
430 02
Country
Czechia
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Research Site
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Research Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Research Site
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Research Site
City
Komarom
ZIP/Postal Code
2991
Country
Hungary
Facility Name
Research Site
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Research Site
City
Lyttelton
State/Province
Gauteng
ZIP/Postal Code
0140
Country
South Africa
Facility Name
Research Site
City
Amanzimtoti
State/Province
KwaZulu-Natal
ZIP/Postal Code
4126
Country
South Africa
Facility Name
Research Site
City
Chatsworth, Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Research Site
City
Observatory
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Research Site
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Research Site
City
Parow
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Research Site
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Research Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
29221604
Citation
Toth PP, Sattar N, Blom DJ, Martin SS, Jones SR, Monsalvo ML, Elliott M, Davis M, Somaratne R, Preiss D. Effect of Evolocumab on Lipoprotein Particles. Am J Cardiol. 2018 Feb 1;121(3):308-314. doi: 10.1016/j.amjcard.2017.10.028. Epub 2017 Nov 8.
Results Reference
background
PubMed Identifier
27619750
Citation
Blom DJ, Koren MJ, Roth E, Monsalvo ML, Djedjos CS, Nelson P, Elliott M, Wasserman SM, Ballantyne CM, Holman RR. Evaluation of the efficacy, safety and glycaemic effects of evolocumab (AMG 145) in hypercholesterolaemic patients stratified by glycaemic status and metabolic syndrome. Diabetes Obes Metab. 2017 Jan;19(1):98-107. doi: 10.1111/dom.12788. Epub 2016 Oct 14.
Results Reference
background
PubMed Identifier
26228031
Citation
Blom DJ, Djedjos CS, Monsalvo ML, Bridges I, Wasserman SM, Scott R, Roth E. Effects of Evolocumab on Vitamin E and Steroid Hormone Levels: Results From the 52-Week, Phase 3, Double-Blind, Randomized, Placebo-Controlled DESCARTES Study. Circ Res. 2015 Sep 25;117(8):731-41. doi: 10.1161/CIRCRESAHA.115.307071. Epub 2015 Jul 30.
Results Reference
background
PubMed Identifier
24678979
Citation
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.
Results Reference
background
PubMed Identifier
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Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study

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