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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04270760
Registration number
NCT04270760
Ethics application status
Date submitted
13/02/2020
Date registered
17/02/2020
Date last updated
7/09/2023
Titles & IDs
Public title
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
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Scientific title
A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a)
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Secondary ID [1]
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2019-003688-23
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Secondary ID [2]
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20180109
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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
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Olpasiran
Treatment: Drugs - Placebo
Active Comparator: Arm 1 Olpasiran Dose 1 -
Active Comparator: Arm 2 Olpasiran Dose 2 -
Active Comparator: Arm 3 Olpasiran Dose 3 -
Active Comparator: Arm 4 Olpasiran Dose 4 -
Placebo Comparator: Arm 5 Placebo Dose 5 -
Treatment: Drugs: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Treatment: Drugs: Placebo
Dose 5
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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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Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36
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Assessment method [1]
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Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
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Timepoint [1]
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Baseline and Week 36
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Secondary outcome [1]
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Percentage Change From Baseline in Lp(a) at Week 48
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Assessment method [1]
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Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
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Timepoint [1]
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Baseline and Week 48
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Secondary outcome [2]
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Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48
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Assessment method [2]
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Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
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Timepoint [2]
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Baseline; Week 36 and Week 48
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Secondary outcome [3]
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Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48
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Assessment method [3]
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Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
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Timepoint [3]
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Baseline; Week 36 and Week 48
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Secondary outcome [4]
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Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
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Assessment method [4]
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Pharmacokinetic blood draws were collected at one timepoint during the 6-12 and 24-72 hour flexible time windows and at Week 48.
Lower limit of quantification (LLOQ) = 0.400 ng/mL. Values below the LLOQ were set to zero.
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Timepoint [4]
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Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48
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Eligibility
Key inclusion criteria
- Age 18 to 80 years
- Lipoprotein (a) > 150 nmol/L
- Evidence of atherosclerotic cardiovascular disease
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Minimum age
18
Years
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Maximum age
80
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
- History or clinical evidence of hepatic dysfunction
- Malignancy within the last 5 years
- Currently receiving, or less than 3 months at Day 1 since receiving > 200 mg/day
Niacin
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
28/07/2020
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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
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Actual
8/11/2022
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Sample size
Target
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Accrual to date
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Final
281
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Core Research Group Pty Ltd - Milton
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Recruitment hospital [3]
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Monash Medical Centre - Clayton
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Recruitment hospital [4]
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Linear Clinical Research Limited - Nedlands
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Recruitment hospital [5]
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Dr Heart Pty Ltd - Woolloongabba
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4064 - Milton
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Recruitment outside Australia
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United States of America
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California
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Florida
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Georgia
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Kansas
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Ontario
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Quebec
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Denmark
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Aarhus N
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Herlev
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Viborg
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Chiba
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Hokkaido
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Japan
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Ishikawa
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Japan
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Saitama
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Netherlands
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Amsterdam
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Arnhem
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The Hague
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Utrecht
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Netherlands
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Venlo
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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
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on
percent change from baseline in lipoprotein(a) (Lp[a]).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04270760
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Trial related presentations / publications
O'Donoghue ML, G Lopez JA, Knusel B, Gencer B, Wang H, Wu Y, Kassahun H, Sabatine MS. Study design and rationale for the Olpasiran trials of Cardiovascular Events And lipoproteiN(a) reduction-DOSE finding study (OCEAN(a)-DOSE). Am Heart J. 2022 Sep;251:61-69. doi: 10.1016/j.ahj.2022.05.004. Epub 2022 May 16.
O'Donoghue ML, Rosenson RS, Gencer B, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Kuder JF, Ran X, Murphy SA, Wang H, Wu Y, Kassahun H, Sabatine MS; OCEAN(a)-DOSE Trial Investigators. Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease. N Engl J Med. 2022 Nov 17;387(20):1855-1864. doi: 10.1056/NEJMoa2211023. Epub 2022 Nov 6.
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Public notes
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Contacts
Principal investigator
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MD
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Address
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04270760
Download to PDF