Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C (ORION-15)
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ClinicalTrials.gov Identifier: NCT04666298 |
Recruitment Status :
Completed
First Posted : December 14, 2020
Results First Posted : May 10, 2023
Last Update Posted : May 10, 2023
|
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Hypercholesterolemia Heterozygous Familial Hypercholesterolemia |
Interventions |
Drug: Inclisiran sodium Drug: Placebo |
Enrollment | 312 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Placebo | 100 mg Inclisiran Sodium | 200 mg Inclisiran Sodium | 300 mg Inclisiran Sodium |
---|---|---|---|---|
Arm/Group Description | Placebo subcutaneous injection | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection |
Period Title: Overall Study | ||||
Started | 57 | 55 | 101 | 99 |
Completed | 55 | 55 | 100 | 95 |
Not Completed | 2 | 0 | 1 | 4 |
Reason Not Completed | ||||
Subject decision | 1 | 0 | 0 | 2 |
Death | 1 | 0 | 0 | 0 |
Lost to Follow-up | 0 | 0 | 0 | 1 |
Physician Decision | 0 | 0 | 0 | 1 |
Protocol deviation | 0 | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo | 100 mg Inclisiran Sodium | 200 mg Inclisiran Sodium | 300 mg Inclisiran Sodium | Total | |
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Arm/Group Description | Placebo subcutaneous injection | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection | Total of all reporting groups | |
Overall Number of Baseline Participants | 57 | 55 | 101 | 99 | 312 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 57 participants | 55 participants | 101 participants | 99 participants | 312 participants | |
63.8 (11.12) | 62.7 (9.25) | 64.7 (10.57) | 63.0 (10.66) | 63.6 (10.46) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 57 participants | 55 participants | 101 participants | 99 participants | 312 participants | |
Female |
18 31.6%
|
19 34.5%
|
21 20.8%
|
22 22.2%
|
80 25.6%
|
|
Male |
39 68.4%
|
36 65.5%
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80 79.2%
|
77 77.8%
|
232 74.4%
|
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 57 participants | 55 participants | 101 participants | 99 participants | 312 participants | |
Japanese |
57 100.0%
|
55 100.0%
|
101 100.0%
|
99 100.0%
|
312 100.0%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Novartis Pharmaceuticals |
Phone: | + 1 862 778 8300 |
EMail: | Novartis.email@Novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
ClinicalTrials.gov Identifier: | NCT04666298 |
Other Study ID Numbers: |
CKJX839A11201 |
First Submitted: | December 7, 2020 |
First Posted: | December 14, 2020 |
Results First Submitted: | April 17, 2023 |
Results First Posted: | May 10, 2023 |
Last Update Posted: | May 10, 2023 |