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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07136012
Registration number
NCT07136012
Ethics application status
Date submitted
18/08/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Titles & IDs
Public title
OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
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Scientific title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)
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Secondary ID [1]
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20230222
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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:
Cardiovascular Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Olpasiran
Treatment: Drugs - Placebo
Experimental: Olpasiran - Participants will receive subcutaneous (SC) olpasiran.
Placebo comparator: Placebo - Participants will receive SC placebo.
Treatment: Drugs: Olpasiran
Olpasiran will be administered via SC injection.
Treatment: Drugs: Placebo
Placebo will be administered via SC injection.
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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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Timepoint [1]
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Up to approximately 6.2 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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Up to approximately 6.2 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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Timepoint [2]
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Up to approximately 6.2 years
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Secondary outcome [3]
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Percent Change From Baseline to Week 48 Lp(a) Levels
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Assessment method [3]
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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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Time to Myocardial Infarction
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Assessment method [4]
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Timepoint [4]
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Up to approximately 6.2 years
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Secondary outcome [5]
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Time to CHD Death or Myocardial Infarction, Whichever Occurs First
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Assessment method [5]
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Timepoint [5]
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Up to approximately 6.2 years
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Secondary outcome [6]
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Time to Urgent Coronary Revascularization
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Assessment method [6]
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Timepoint [6]
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Up to approximately 6.2 years
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Secondary outcome [7]
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Time to Coronary Revascularization
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Assessment method [7]
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Timepoint [7]
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Up to approximately 6.2 years
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Secondary outcome [8]
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Time to CHD Death
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Assessment method [8]
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Timepoint [8]
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Up to approximately 6.2 years
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Secondary outcome [9]
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Time to Cardiovascular Death
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Assessment method [9]
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Timepoint [9]
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Up to approximately 6.2 years
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Secondary outcome [10]
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Time to Death by any Cause
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Assessment method [10]
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Timepoint [10]
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Up to approximately 6.2 years
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Secondary outcome [11]
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Time to Ischemic Stroke
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Assessment method [11]
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Timepoint [11]
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Up to approximately 6.2 years
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Secondary outcome [12]
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Serum Concentration of Olpasiran
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Assessment method [12]
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Timepoint [12]
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Up to Week 48
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Secondary outcome [13]
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Number of Participants with Treatment Emergent Adverse Events (TEAEs)
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Assessment method [13]
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Including serious adverse events and adverse events leading to discontinuation of investigational product.
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Timepoint [13]
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Up to approximately 6.2 years
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Eligibility
Key inclusion criteria
* Age =50 years
* Lp(a)= 200 nmol/L during screening
* Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
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Minimum age
50
Years
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Maximum age
105
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
* Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
* Prior or planned arterial revascularization
* History of major bleeding disorder
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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
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
19/09/2025
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Actual
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
18/10/2031
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Actual
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Sample size
Target
11000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
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Recruitment hospital [1]
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Advara HeartCare Wesley - Auchenflower
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Recruitment hospital [2]
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University of The Sunshine Coast Clinical Trials, Sippy Downs - Sippy Downs
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Recruitment hospital [3]
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Dr Heart Pty Ltd - Woolloongabba
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Recruitment hospital [4]
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Advara HeartCare Leabrook - Leabrook
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Recruitment hospital [5]
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Fusion Clinical Research - Norwood
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Recruitment hospital [6]
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Advara HeartCare Joondalup - Joondalup
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Recruitment postcode(s) [1]
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4066 - Auchenflower
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Recruitment postcode(s) [2]
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4556 - Sippy Downs
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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5068 - Leabrook
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Recruitment postcode(s) [5]
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5067 - Norwood
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Recruitment postcode(s) [6]
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6027 - Joondalup
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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California
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Florida
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Georgia
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Idaho
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Michigan
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North Carolina
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Ohio
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Tennessee
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Texas
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Virginia
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Canada
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British Columbia
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Canada
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State/province [21]
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Ontario
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).
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Trial website
https://clinicaltrials.gov/study/NCT07136012
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Amgen Call Center
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Address
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Country
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Phone
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866-572-6436
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Fax
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Email
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[email protected]
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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
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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)
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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.
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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?
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How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing
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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/NCT07136012
Download to PDF