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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04270760




Registration number
NCT04270760
Ethics application status
Date submitted
13/02/2020
Date registered
17/02/2020

Titles & IDs
Public title
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
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)
Secondary ID [1] 0 0
2019-003688-23
Secondary ID [2] 0 0
20180109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36
Timepoint [1] 0 0
Baseline and Week 36
Secondary outcome [1] 0 0
Percentage Change From Baseline in Lp(a) at Week 48
Timepoint [1] 0 0
Baseline and Week 48
Secondary outcome [2] 0 0
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48
Timepoint [2] 0 0
Baseline; Week 36 and Week 48
Secondary outcome [3] 0 0
Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48
Timepoint [3] 0 0
Baseline; Week 36 and Week 48
Secondary outcome [4] 0 0
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Timepoint [4] 0 0
Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48

Eligibility
Key inclusion criteria
* Age 18 to 80 years
* Lipoprotein (a) > 150 nmol/L
* Evidence of atherosclerotic cardiovascular disease
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
28/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/11/2022
Sample size
Target
Accrual to date
Final
281
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Core Research Group Pty Ltd - Milton
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment hospital [5] 0 0
Dr Heart Pty Ltd - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Denmark
State/province [12] 0 0
Aarhus N
Country [13] 0 0
Denmark
State/province [13] 0 0
Herlev
Country [14] 0 0
Denmark
State/province [14] 0 0
Viborg
Country [15] 0 0
Iceland
State/province [15] 0 0
Kopavogur
Country [16] 0 0
Japan
State/province [16] 0 0
Chiba
Country [17] 0 0
Japan
State/province [17] 0 0
Hokkaido
Country [18] 0 0
Japan
State/province [18] 0 0
Ishikawa
Country [19] 0 0
Japan
State/province [19] 0 0
Saitama
Country [20] 0 0
Netherlands
State/province [20] 0 0
Amsterdam
Country [21] 0 0
Netherlands
State/province [21] 0 0
Arnhem
Country [22] 0 0
Netherlands
State/province [22] 0 0
The Hague
Country [23] 0 0
Netherlands
State/province [23] 0 0
Utrecht
Country [24] 0 0
Netherlands
State/province [24] 0 0
Venlo

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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 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.
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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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 URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04270760