Clinical trial
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein…
NCT03397121 · The Medicines Company, Industry · Completed
Key facts
| NCT number | NCT03397121 |
|---|---|
| Title | Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) |
| Official title | Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C). |
| Acronym | ORION-9 |
| Lead sponsor | The Medicines Company, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Heterozygous Familial Hypercholesterolemia, Elevated Cholesterol |
| Intervention type | Drug |
| Interventions | Inclisiran, Placebo |
| Enrollment | 482 |
| Start date | Nov 28, 2017 |
| Primary completion | Aug 27, 2019 |
| Completion | Sep 17, 2019 |
| First posted | Jan 11, 2018 |
| Last update posted | Oct 28, 2020 |
| Countries | Canada, Czechia, Denmark, Netherlands, South Africa, Spain, Sweden, United States |
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: