Clinical trial
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated…
NCT03400800 · The Medicines Company, Industry · Completed
Key facts
| NCT number | NCT03400800 |
|---|---|
| Title | Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol |
| Official title | A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) or ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C) |
| Acronym | ORION-11 |
| Lead sponsor | The Medicines Company, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol |
| Intervention type | Drug |
| Interventions | Inclisiran Sodium, Placebo |
| Enrollment | 1,617 |
| Start date | Nov 1, 2017 |
| Primary completion | Jul 31, 2019 |
| Completion | Aug 27, 2019 |
| First posted | Jan 17, 2018 |
| Last update posted | Aug 21, 2020 |
| Countries | Czechia, Germany, Hungary, Poland, South Africa, Ukraine, United Kingdom |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: