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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05581303
Registration number
NCT05581303
Ethics application status
Date submitted
12/10/2022
Date registered
14/10/2022
Titles & IDs
Public title
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
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Scientific title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
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Secondary ID [1]
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0
20180244
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease
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0
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Condition category
Condition code
Cardiovascular
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0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Olpasiran
Placebo comparator: Placebo - Placebo will be administered by subcutaneous injection
Experimental: Olpasiran - Olpasiran will be administered by subcutaneous injection
Treatment: Drugs: Placebo
Placebo given by subcutaneous injection once every 12 weeks (Q12W).
Treatment: Drugs: Olpasiran
Olpasiran given by subcutaneous injection Q12W.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first
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Assessment method [1]
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0
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Timepoint [1]
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Approximately 4 years
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Secondary outcome [1]
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Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first
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Assessment method [1]
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Timepoint [1]
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Approximately 4 years
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Secondary outcome [2]
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Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first
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Assessment method [2]
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0
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Timepoint [2]
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Approximately 4 years
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Secondary outcome [3]
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Percent change from baseline to Week 48 in Lipoprotein(a)
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Assessment method [3]
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0
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Timepoint [3]
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Baseline and Week 48
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Secondary outcome [4]
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0
Time to myocardial infarction
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Assessment method [4]
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0
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Timepoint [4]
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0
Approximately 4 years
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Secondary outcome [5]
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0
Time to CHD death or myocardial infarction, whichever occurs first
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Assessment method [5]
0
0
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Timepoint [5]
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0
Approximately 4 years
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Secondary outcome [6]
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0
Time to urgent coronary revascularization
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Assessment method [6]
0
0
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Timepoint [6]
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Approximately 4 years
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Secondary outcome [7]
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0
Time to coronary revascularization
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Assessment method [7]
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0
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Timepoint [7]
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0
Approximately 4 years
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Secondary outcome [8]
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0
Time to CHD death
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Assessment method [8]
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0
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Timepoint [8]
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0
Approximately 4 years
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Secondary outcome [9]
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0
Time to cardiovascular death
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Assessment method [9]
0
0
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Timepoint [9]
0
0
Approximately 4 years
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Secondary outcome [10]
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0
Time to death by any cause
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Assessment method [10]
0
0
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Timepoint [10]
0
0
Approximately 4 years
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Secondary outcome [11]
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Time to ischemic stroke
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Assessment method [11]
0
0
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Timepoint [11]
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Approximately 4 years
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Eligibility
Key inclusion criteria
* Age 18 to = 85 years
* Lp(a)= 200 nmol/L during screening
* History of ASCVD as evidenced by history of either:
* Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or
* Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Severe renal dysfunction
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening
* History of hemorrhagic stroke
* History of major bleeding disorder
* Planned cardiac surgery or arterial revascularization
* Severe heart failure
* Current, recent, or planned lipoprotein apheresis
* Previously received ribonucleic acid therapy specifically targeting Lp(a)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/12/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
7297
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Garran
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [4]
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Liverpool Hospital - Liverpool
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Recruitment hospital [5]
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Holdsworth House Medical Practice - Sydney
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Recruitment hospital [6]
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Wollongong Hospital - Wollongong
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Recruitment hospital [7]
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Advara HeartCare Wesley - Auchenflower
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Recruitment hospital [8]
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Advara HeartCare Bundaberg - Bundaberg
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Recruitment hospital [9]
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Royal Brisbane and Womens Hospital - Herston
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Recruitment hospital [10]
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Core Research Group Pty Ltd - Milton
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Recruitment hospital [11]
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Dr Heart Pty Ltd - Woolloongabba
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Recruitment hospital [12]
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Nightingale Research - Adelaide
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Recruitment hospital [13]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [14]
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Advara HeartCare Leabrook - Leabrook
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Recruitment hospital [15]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [16]
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Advara HeartCare Berwick - Berwick
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Victorian Heart Hospital - Clayton
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Recruitment hospital [18]
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The Cardiologists Proprietary Limited - Epping
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Barwon Health Geelong Hospital - Geelong
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Advara HeartCare Ringwood - Ringwood
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Advara HeartCare Joondalup - Joondalup
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Recruitment hospital [22]
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Mount Hospital - Murdoch
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Recruitment hospital [23]
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Linear Clinical Research Limited - Nedlands
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2139 - Concord
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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2010 - Sydney
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Recruitment postcode(s) [6]
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2500 - Wollongong
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Recruitment postcode(s) [7]
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4066 - Auchenflower
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Recruitment postcode(s) [8]
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4670 - Bundaberg
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Recruitment postcode(s) [9]
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4029 - Herston
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Recruitment postcode(s) [10]
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4064 - Milton
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Recruitment postcode(s) [11]
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4102 - Woolloongabba
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Recruitment postcode(s) [12]
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5000 - Adelaide
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Recruitment postcode(s) [13]
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5042 - Bedford Park
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Recruitment postcode(s) [14]
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5068 - Leabrook
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Recruitment postcode(s) [15]
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7000 - Hobart
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Recruitment postcode(s) [16]
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3806 - Berwick
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Recruitment postcode(s) [17]
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3168 - Clayton
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Recruitment postcode(s) [18]
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3076 - Epping
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Recruitment postcode(s) [19]
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3220 - Geelong
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Recruitment postcode(s) [20]
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3134 - Ringwood
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Recruitment postcode(s) [21]
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6027 - Joondalup
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Recruitment postcode(s) [22]
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6150 - Murdoch
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Recruitment postcode(s) [23]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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Alaska
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Colorado
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Connecticut
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Idaho
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Illinois
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Sankt Poelten
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Rio de Janeiro
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Blagoevgrad
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Stara Zagora
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Canada
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Canada
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Ontario
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China
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Beijing
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China
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Jilin
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China
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0
Shanghai
Query!
Country [105]
0
0
China
Query!
State/province [105]
0
0
Wuhan
Query!
Country [106]
0
0
Czechia
Query!
State/province [106]
0
0
Beroun
Query!
Country [107]
0
0
Czechia
Query!
State/province [107]
0
0
Bilina
Query!
Country [108]
0
0
Czechia
Query!
State/province [108]
0
0
Brandys nad Labem
Query!
Country [109]
0
0
Czechia
Query!
State/province [109]
0
0
Brno
Query!
Country [110]
0
0
Czechia
Query!
State/province [110]
0
0
Ceske Budejovice
Query!
Country [111]
0
0
Czechia
Query!
State/province [111]
0
0
Chomutov
Query!
Country [112]
0
0
Czechia
Query!
State/province [112]
0
0
Havirov - Mesto
Query!
Country [113]
0
0
Czechia
Query!
State/province [113]
0
0
Holesov
Query!
Country [114]
0
0
Czechia
Query!
State/province [114]
0
0
Hradec Kralove
Query!
Country [115]
0
0
Czechia
Query!
State/province [115]
0
0
Jihlava
Query!
Country [116]
0
0
Czechia
Query!
State/province [116]
0
0
Klatovy IV
Query!
Country [117]
0
0
Czechia
Query!
State/province [117]
0
0
Mlada Boleslav
Query!
Country [118]
0
0
Czechia
Query!
State/province [118]
0
0
Nachod
Query!
Country [119]
0
0
Czechia
Query!
State/province [119]
0
0
Olomouc
Query!
Country [120]
0
0
Czechia
Query!
State/province [120]
0
0
Ostrava - Moravska Ostrava
Query!
Country [121]
0
0
Czechia
Query!
State/province [121]
0
0
Ostrava-Dubina
Query!
Country [122]
0
0
Czechia
Query!
State/province [122]
0
0
Ostrava
Query!
Country [123]
0
0
Czechia
Query!
State/province [123]
0
0
Pardubice
Query!
Country [124]
0
0
Czechia
Query!
State/province [124]
0
0
Plzen
Query!
Country [125]
0
0
Czechia
Query!
State/province [125]
0
0
Policka
Query!
Country [126]
0
0
Czechia
Query!
State/province [126]
0
0
Praha 10
Query!
Country [127]
0
0
Czechia
Query!
State/province [127]
0
0
Praha 2
Query!
Country [128]
0
0
Czechia
Query!
State/province [128]
0
0
Praha 4
Query!
Country [129]
0
0
Czechia
Query!
State/province [129]
0
0
Praha 5 - Smichov
Query!
Country [130]
0
0
Czechia
Query!
State/province [130]
0
0
Praha 5
Query!
Country [131]
0
0
Czechia
Query!
State/province [131]
0
0
Praha 9
Query!
Country [132]
0
0
Czechia
Query!
State/province [132]
0
0
Prerov
Query!
Country [133]
0
0
Czechia
Query!
State/province [133]
0
0
Pribram VIII
Query!
Country [134]
0
0
Czechia
Query!
State/province [134]
0
0
Trutnov
Query!
Country [135]
0
0
Czechia
Query!
State/province [135]
0
0
Uherske Hradiste
Query!
Country [136]
0
0
Czechia
Query!
State/province [136]
0
0
Zlin
Query!
Country [137]
0
0
Denmark
Query!
State/province [137]
0
0
Aalborg
Query!
Country [138]
0
0
Denmark
Query!
State/province [138]
0
0
Aarhus N
Query!
Country [139]
0
0
Denmark
Query!
State/province [139]
0
0
Copenhagen O
Query!
Country [140]
0
0
Denmark
Query!
State/province [140]
0
0
Esbjerg
Query!
Country [141]
0
0
Denmark
Query!
State/province [141]
0
0
Gandrup
Query!
Country [142]
0
0
Denmark
Query!
State/province [142]
0
0
Herlev
Query!
Country [143]
0
0
Denmark
Query!
State/province [143]
0
0
Herning
Query!
Country [144]
0
0
Denmark
Query!
State/province [144]
0
0
Holbaek
Query!
Country [145]
0
0
Denmark
Query!
State/province [145]
0
0
Kobenhavn NV
Query!
Country [146]
0
0
Denmark
Query!
State/province [146]
0
0
Kobenhavn S
Query!
Country [147]
0
0
Denmark
Query!
State/province [147]
0
0
Roskilde
Query!
Country [148]
0
0
Denmark
Query!
State/province [148]
0
0
Slagelse
Query!
Country [149]
0
0
Denmark
Query!
State/province [149]
0
0
Svendborg
Query!
Country [150]
0
0
Denmark
Query!
State/province [150]
0
0
Vejle
Query!
Country [151]
0
0
Denmark
Query!
State/province [151]
0
0
Viborg
Query!
Country [152]
0
0
Estonia
Query!
State/province [152]
0
0
Tallinn
Query!
Country [153]
0
0
Estonia
Query!
State/province [153]
0
0
Tartu
Query!
Country [154]
0
0
Finland
Query!
State/province [154]
0
0
Helsinki
Query!
Country [155]
0
0
Finland
Query!
State/province [155]
0
0
Kuopio
Query!
Country [156]
0
0
Finland
Query!
State/province [156]
0
0
Oulu
Query!
Country [157]
0
0
Finland
Query!
State/province [157]
0
0
Tampere
Query!
Country [158]
0
0
Finland
Query!
State/province [158]
0
0
Turku
Query!
Country [159]
0
0
France
Query!
State/province [159]
0
0
Besancon cedex
Query!
Country [160]
0
0
France
Query!
State/province [160]
0
0
Bron cedex
Query!
Country [161]
0
0
France
Query!
State/province [161]
0
0
Chambray les Tours
Query!
Country [162]
0
0
France
Query!
State/province [162]
0
0
Compiegne
Query!
Country [163]
0
0
France
Query!
State/province [163]
0
0
Dijon
Query!
Country [164]
0
0
France
Query!
State/province [164]
0
0
Lille Cedex
Query!
Country [165]
0
0
France
Query!
State/province [165]
0
0
Marseille Cedex 08
Query!
Country [166]
0
0
France
Query!
State/province [166]
0
0
Marseille
Query!
Country [167]
0
0
France
Query!
State/province [167]
0
0
Montpellier cedex 05
Query!
Country [168]
0
0
France
Query!
State/province [168]
0
0
Nantes Cedex 1
Query!
Country [169]
0
0
France
Query!
State/province [169]
0
0
Nice Cedex 1
Query!
Country [170]
0
0
France
Query!
State/province [170]
0
0
Paris Cedex 13
Query!
Country [171]
0
0
France
Query!
State/province [171]
0
0
Paris Cedex 18
Query!
Country [172]
0
0
France
Query!
State/province [172]
0
0
Paris
Query!
Country [173]
0
0
France
Query!
State/province [173]
0
0
Reims
Query!
Country [174]
0
0
France
Query!
State/province [174]
0
0
Rennes
Query!
Country [175]
0
0
France
Query!
State/province [175]
0
0
Strasbourg
Query!
Country [176]
0
0
France
Query!
State/province [176]
0
0
Toulouse Cedex 9
Query!
Country [177]
0
0
France
Query!
State/province [177]
0
0
Valenciennes
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Aachen
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Bad Krozingen
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Bad Oeynhausen
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Berlin
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Bremen
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Dresden
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Essen
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Frankfurt am Main
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Goettingen
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Hamburg
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Heidelberg
Query!
Country [189]
0
0
Germany
Query!
State/province [189]
0
0
Kassel
Query!
Country [190]
0
0
Germany
Query!
State/province [190]
0
0
Koeln
Query!
Country [191]
0
0
Germany
Query!
State/province [191]
0
0
Leipzig
Query!
Country [192]
0
0
Germany
Query!
State/province [192]
0
0
Magdeburg
Query!
Country [193]
0
0
Germany
Query!
State/province [193]
0
0
Mannheim
Query!
Country [194]
0
0
Germany
Query!
State/province [194]
0
0
Markkleeberg
Query!
Country [195]
0
0
Germany
Query!
State/province [195]
0
0
Muenchen
Query!
Country [196]
0
0
Germany
Query!
State/province [196]
0
0
Muenster
Query!
Country [197]
0
0
Germany
Query!
State/province [197]
0
0
Papenburg
Query!
Country [198]
0
0
Germany
Query!
State/province [198]
0
0
Remscheid
Query!
Country [199]
0
0
Germany
Query!
State/province [199]
0
0
Rostock
Query!
Country [200]
0
0
Germany
Query!
State/province [200]
0
0
Ruedersdorf
Query!
Country [201]
0
0
Germany
Query!
State/province [201]
0
0
Singen
Query!
Country [202]
0
0
Germany
Query!
State/province [202]
0
0
Witten
Query!
Country [203]
0
0
Greece
Query!
State/province [203]
0
0
Athens
Query!
Country [204]
0
0
Greece
Query!
State/province [204]
0
0
Heraklion
Query!
Country [205]
0
0
Greece
Query!
State/province [205]
0
0
Ioannina
Query!
Country [206]
0
0
Greece
Query!
State/province [206]
0
0
Mitilini
Query!
Country [207]
0
0
Greece
Query!
State/province [207]
0
0
Thessaloniki
Query!
Country [208]
0
0
Hong Kong
Query!
State/province [208]
0
0
Hong Kong
Query!
Country [209]
0
0
Hong Kong
Query!
State/province [209]
0
0
Shatin, New Territories
Query!
Country [210]
0
0
Hungary
Query!
State/province [210]
0
0
Baja
Query!
Country [211]
0
0
Hungary
Query!
State/province [211]
0
0
Bekescsaba
Query!
Country [212]
0
0
Hungary
Query!
State/province [212]
0
0
Budapest
Query!
Country [213]
0
0
Hungary
Query!
State/province [213]
0
0
Debrecen
Query!
Country [214]
0
0
Hungary
Query!
State/province [214]
0
0
Gyongyos
Query!
Country [215]
0
0
Hungary
Query!
State/province [215]
0
0
Hatvan
Query!
Country [216]
0
0
Hungary
Query!
State/province [216]
0
0
Komarom
Query!
Country [217]
0
0
Hungary
Query!
State/province [217]
0
0
Miskolc
Query!
Country [218]
0
0
Hungary
Query!
State/province [218]
0
0
Oroshaza
Query!
Country [219]
0
0
Hungary
Query!
State/province [219]
0
0
Szekesfehervar
Query!
Country [220]
0
0
Hungary
Query!
State/province [220]
0
0
Zalaegerszeg
Query!
Country [221]
0
0
Iceland
Query!
State/province [221]
0
0
Kopavogur
Query!
Country [222]
0
0
Italy
Query!
State/province [222]
0
0
Arzignano
Query!
Country [223]
0
0
Italy
Query!
State/province [223]
0
0
Bologna
Query!
Country [224]
0
0
Italy
Query!
State/province [224]
0
0
Brescia
Query!
Country [225]
0
0
Italy
Query!
State/province [225]
0
0
Caserta
Query!
Country [226]
0
0
Italy
Query!
State/province [226]
0
0
Catania
Query!
Country [227]
0
0
Italy
Query!
State/province [227]
0
0
Catanzaro
Query!
Country [228]
0
0
Italy
Query!
State/province [228]
0
0
Cona FE
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
Firenze
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
Genova
Query!
Country [231]
0
0
Italy
Query!
State/province [231]
0
0
Milano
Query!
Country [232]
0
0
Italy
Query!
State/province [232]
0
0
Napoli
Query!
Country [233]
0
0
Italy
Query!
State/province [233]
0
0
Palermo
Query!
Country [234]
0
0
Italy
Query!
State/province [234]
0
0
Rivoli
Query!
Country [235]
0
0
Italy
Query!
State/province [235]
0
0
Roma
Query!
Country [236]
0
0
Italy
Query!
State/province [236]
0
0
Rozzano MI
Query!
Country [237]
0
0
Italy
Query!
State/province [237]
0
0
Salerno
Query!
Country [238]
0
0
Italy
Query!
State/province [238]
0
0
Sesto San Giovanni (MI)
Query!
Country [239]
0
0
Italy
Query!
State/province [239]
0
0
Torino
Query!
Country [240]
0
0
Japan
Query!
State/province [240]
0
0
Aichi
Query!
Country [241]
0
0
Japan
Query!
State/province [241]
0
0
Aomori
Query!
Country [242]
0
0
Japan
Query!
State/province [242]
0
0
Chiba
Query!
Country [243]
0
0
Japan
Query!
State/province [243]
0
0
Fukui
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Fukuoka
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Gifu
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Hiroshima
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Hokkaido
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Hyogo
Query!
Country [249]
0
0
Japan
Query!
State/province [249]
0
0
Ishikawa
Query!
Country [250]
0
0
Japan
Query!
State/province [250]
0
0
Iwate
Query!
Country [251]
0
0
Japan
Query!
State/province [251]
0
0
Kagawa
Query!
Country [252]
0
0
Japan
Query!
State/province [252]
0
0
Kagoshima
Query!
Country [253]
0
0
Japan
Query!
State/province [253]
0
0
Kanagawa
Query!
Country [254]
0
0
Japan
Query!
State/province [254]
0
0
Kochi
Query!
Country [255]
0
0
Japan
Query!
State/province [255]
0
0
Kumamoto
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Miyagi
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Miyazaki
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Nagano
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Niigata
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Okayama
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Osaka
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Saga
Query!
Country [263]
0
0
Japan
Query!
State/province [263]
0
0
Saitama
Query!
Country [264]
0
0
Japan
Query!
State/province [264]
0
0
Shizuoka
Query!
Country [265]
0
0
Japan
Query!
State/province [265]
0
0
Tokyo
Query!
Country [266]
0
0
Japan
Query!
State/province [266]
0
0
Toyama
Query!
Country [267]
0
0
Japan
Query!
State/province [267]
0
0
Wakayama
Query!
Country [268]
0
0
Japan
Query!
State/province [268]
0
0
Yamaguchi
Query!
Country [269]
0
0
Japan
Query!
State/province [269]
0
0
Yamanashi
Query!
Country [270]
0
0
Korea, Republic of
Query!
State/province [270]
0
0
Busan
Query!
Country [271]
0
0
Korea, Republic of
Query!
State/province [271]
0
0
Gwangju
Query!
Country [272]
0
0
Korea, Republic of
Query!
State/province [272]
0
0
Incheon
Query!
Country [273]
0
0
Korea, Republic of
Query!
State/province [273]
0
0
Seongnam-si, Gyeonggi-do
Query!
Country [274]
0
0
Korea, Republic of
Query!
State/province [274]
0
0
Seoul
Query!
Country [275]
0
0
Korea, Republic of
Query!
State/province [275]
0
0
Ulsan
Query!
Country [276]
0
0
Korea, Republic of
Query!
State/province [276]
0
0
Wonju-si, Gangwon-do
Query!
Country [277]
0
0
Lithuania
Query!
State/province [277]
0
0
Alytus
Query!
Country [278]
0
0
Lithuania
Query!
State/province [278]
0
0
Kaunas
Query!
Country [279]
0
0
Lithuania
Query!
State/province [279]
0
0
Klaipeda
Query!
Country [280]
0
0
Lithuania
Query!
State/province [280]
0
0
Siauliai
Query!
Country [281]
0
0
Lithuania
Query!
State/province [281]
0
0
Vilnius
Query!
Country [282]
0
0
Mexico
Query!
State/province [282]
0
0
Jalisco
Query!
Country [283]
0
0
Mexico
Query!
State/province [283]
0
0
Nuevo León
Query!
Country [284]
0
0
Mexico
Query!
State/province [284]
0
0
Sinaloa
Query!
Country [285]
0
0
Mexico
Query!
State/province [285]
0
0
Veracruz
Query!
Country [286]
0
0
Mexico
Query!
State/province [286]
0
0
Aguascalientes
Query!
Country [287]
0
0
Mexico
Query!
State/province [287]
0
0
Chihuahua
Query!
Country [288]
0
0
Mexico
Query!
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Stevenage
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).
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Trial website
https://clinicaltrials.gov/study/NCT05581303
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
MD
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Address
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Amgen
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Query!
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing
Query!
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 not provided in
https://clinicaltrials.gov/study/NCT05581303