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Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study

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ClinicalTrials.gov Identifier: NCT04270760
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: Olpasiran Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : July 28, 2020
Estimated Primary Completion Date : January 17, 2022
Estimated Study Completion Date : April 13, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1 Olpasiran Dose 1 Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890
Active Comparator: Arm 2 Olpasiran Dose 2 Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890
Active Comparator: Arm 3 Olpasiran Dose 3 Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890
Active Comparator: Arm 4 Olpasiran Dose 4 Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890
Placebo Comparator: Arm 5 Placebo Dose 5 Drug: Placebo
Dose 5


Outcome Measures
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Primary Outcome Measures :
  1. Percent change in Lp(a) [ Time Frame: Baseline and week 36 ]

Secondary Outcome Measures :
  1. Percentage change from baseline in Lp(a) [ Time Frame: Baseline and week 48 ]
  2. Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline and Weeks 36 and 48 ]
  3. Percentage change in Apolipoprotein(B) (ApoB) [ Time Frame: Baseline and weeks 36 and 48 ]
  4. Maximum observed concentration (Cmax) of Olpasiran [ Time Frame: 48 weeks ]
  5. Area under the concentration-time curve (AUC) of Olpasiran [ Time Frame: 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 80 years
  • Lipoprotein (a) > 150 nmol/L
  • Evidence of atherosclerotic cardiovascular disease

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04270760


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
Research Site Recruiting
Beverly Hills, California, United States, 90211
United States, Florida
Research Site Recruiting
Boca Raton, Florida, United States, 33434
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30309
United States, Kansas
Research Site Recruiting
Kansas City, Kansas, United States, 66160
United States, Maryland
Research Site Recruiting
Baltimore, Maryland, United States, 21287
United States, New York
Research Site Recruiting
New York, New York, United States, 10016
Research Site Recruiting
New York, New York, United States, 10029
Research Site Recruiting
New York, New York, United States, 10032
United States, North Carolina
Research Site Recruiting
Mooresville, North Carolina, United States, 28117
United States, Ohio
Research Site Recruiting
Cleveland, Ohio, United States, 44195
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
Research Site Recruiting
Hurst, Texas, United States, 76054
Australia, New South Wales
Research Site Recruiting
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Research Site Recruiting
Milton, Queensland, Australia, 4064
Australia, Victoria
Research Site Recruiting
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Research Site Recruiting
Nedlands, Western Australia, Australia, 6009
Australia
Research Site Recruiting
Woolloongabba, Australia, 4102
Canada, Ontario
Research Site Recruiting
Brampton, Ontario, Canada, L6S 0C6
Research Site Recruiting
Concord, Ontario, Canada, L4K 4M2
Canada, Quebec
Research Site Recruiting
Chicoutimi, Quebec, Canada, G7H 7K9
Research Site Recruiting
Montreal, Quebec, Canada, H4A 3J1
Canada
Research Site Recruiting
Quebec, Canada, G1V 4W2
Denmark
Research Site Recruiting
Aarhus N, Denmark, 8200
Research Site Recruiting
Herlev, Denmark, 2730
Research Site Recruiting
Viborg, Denmark, 8800
Iceland
Research Site Recruiting
Kopavogur, Iceland, 201
Japan
Research Site Recruiting
Asahi-shi, Chiba, Japan, 289-2511
Research Site Recruiting
Kashiwa-shi, Chiba, Japan, 277-8567
Research Site Recruiting
Asahikawa-shi, Hokkaido, Japan, 070-8610
Research Site Recruiting
Kahoku-gun, Ishikawa, Japan, 920-0293
Research Site Recruiting
Iruma-gun, Saitama, Japan, 350-0495
Netherlands
Research Site Recruiting
Amsterdam, Netherlands, 1105 AZ
Research Site Recruiting
Arnhem, Netherlands, 6815 AD
Research Site Recruiting
The Hague, Netherlands, 2545 AA
Research Site Recruiting
Utrecht, Netherlands, 3584 CX
Research Site Recruiting
Venlo, Netherlands, 5912 BL
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04270760    
Other Study ID Numbers: 20180109
2019-003688-23 ( EudraCT Number )
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
AMG 890
Olpasiran
siRNA
lipoprotein (a) Lp(a)
Cardiovascular
Cardiovascular disease
 Atherosclerotic cardiovascular disease
Cholesterol
Apolipoprotein (B)
Hyperlipidemia
Dyslipidemia
Additional relevant MeSH terms:
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Cardiovascular Diseases