Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01516879




Registration number
NCT01516879
Ethics application status
Date submitted
18/01/2012
Date registered
25/01/2012
Date last updated
22/07/2022

Titles & IDs
Public title
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
Scientific 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
Secondary ID [1] 0 0
20110109
Universal Trial Number (UTN)
Trial acronym
DESCARTES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Evolocumab
Treatment: Other - Placebo
Treatment: Drugs - Atorvastatin
Treatment: Drugs - Ezetimibe
Other interventions - Diet Only

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

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


Treatment: Other: Evolocumab
Administered by subcutaneous injection once a month

Treatment: Other: Placebo
Administered by subcutaneous injection once a month

Treatment: Drugs: Atorvastatin
Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.

Treatment: Drugs: Ezetimibe
Background lipid lowering therapy: ezetimibe 10 mg orally once a day

Other interventions: Diet Only
Diet only, no lipid lowering background drug given
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in LDL-C at Week 52
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [1] 0 0
Change From Baseline in LDL-C at Week 52
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
Percentage of Participants With an LDL-C Response at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percent Change From Baseline in LDL-C at Week 12
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Percent Change From Baseline in Total Cholesterol at Week 12
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Percent Change From Baseline in Total Cholesterol at Week 52
Timepoint [5] 0 0
Baseline and Week 52
Secondary outcome [6] 0 0
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52
Timepoint [6] 0 0
Baseline and Week 52
Secondary outcome [7] 0 0
Percent Change From Baseline in Apolipoprotein B at Week 52
Timepoint [7] 0 0
Baseline and Week 52
Secondary outcome [8] 0 0
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52
Timepoint [8] 0 0
Baseline and Week 52
Secondary outcome [9] 0 0
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52
Timepoint [9] 0 0
Baseline and Week 52
Secondary outcome [10] 0 0
Percent Change From Baseline in Lipoprotein(a) at Week 52
Timepoint [10] 0 0
Baseline and Week 52
Secondary outcome [11] 0 0
Percent Change From Baseline in Triglycerides at Week 52
Timepoint [11] 0 0
Baseline and Week 52
Secondary outcome [12] 0 0
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52
Timepoint [12] 0 0
Baseline and Week 52
Secondary outcome [13] 0 0
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52
Timepoint [13] 0 0
Baseline and Week 52
Secondary outcome [14] 0 0
Percent Change From Week 12 to Week 52 in LDL-C
Timepoint [14] 0 0
Week 12 and Week 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/10/2013
Sample size
Target
Accrual to date
Final
905
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Maroubra
Recruitment hospital [3] 0 0
Research Site - Carina Heights
Recruitment hospital [4] 0 0
Research Site - Milton
Recruitment hospital [5] 0 0
Research Site - Fitzroy
Recruitment hospital [6] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
2015 - Camperdown
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
4152 - Carina Heights
Recruitment postcode(s) [4] 0 0
4064 - Milton
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
North Dakota
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
South Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Austria
State/province [26] 0 0
Feldkirch
Country [27] 0 0
Austria
State/province [27] 0 0
Innsbruck
Country [28] 0 0
Austria
State/province [28] 0 0
Salzburg
Country [29] 0 0
Austria
State/province [29] 0 0
Wels
Country [30] 0 0
Belgium
State/province [30] 0 0
Anthée
Country [31] 0 0
Belgium
State/province [31] 0 0
Bruxelles
Country [32] 0 0
Belgium
State/province [32] 0 0
Gent
Country [33] 0 0
Belgium
State/province [33] 0 0
Gozee
Country [34] 0 0
Belgium
State/province [34] 0 0
Ham
Country [35] 0 0
Belgium
State/province [35] 0 0
Oostende
Country [36] 0 0
Canada
State/province [36] 0 0
British Columbia
Country [37] 0 0
Canada
State/province [37] 0 0
Newfoundland and Labrador
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Czechia
State/province [40] 0 0
Brno
Country [41] 0 0
Czechia
State/province [41] 0 0
Chomutov
Country [42] 0 0
Czechia
State/province [42] 0 0
Hradec Kralove
Country [43] 0 0
Czechia
State/province [43] 0 0
Pardubice
Country [44] 0 0
Czechia
State/province [44] 0 0
Plzen
Country [45] 0 0
Czechia
State/province [45] 0 0
Praha 2
Country [46] 0 0
Czechia
State/province [46] 0 0
Praha 4
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 5
Country [48] 0 0
Czechia
State/province [48] 0 0
Slany
Country [49] 0 0
Denmark
State/province [49] 0 0
Aalborg
Country [50] 0 0
Denmark
State/province [50] 0 0
Ballerup
Country [51] 0 0
Denmark
State/province [51] 0 0
Vejle
Country [52] 0 0
Hungary
State/province [52] 0 0
Baja
Country [53] 0 0
Hungary
State/province [53] 0 0
Budapest
Country [54] 0 0
Hungary
State/province [54] 0 0
Komarom
Country [55] 0 0
Hungary
State/province [55] 0 0
Pecs
Country [56] 0 0
Hungary
State/province [56] 0 0
Szeged
Country [57] 0 0
Hungary
State/province [57] 0 0
Zalaegerszeg
Country [58] 0 0
South Africa
State/province [58] 0 0
Gauteng
Country [59] 0 0
South Africa
State/province [59] 0 0
KwaZulu-Natal
Country [60] 0 0
South Africa
State/province [60] 0 0
Western Cape
Country [61] 0 0
South Africa
State/province [61] 0 0
Bloemfontein

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01516879