Trials / Completed
CompletedNCT03400800
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,617 (actual)
- Sponsor
- The Medicines Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inclisiran Sodium | Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis. |
| DRUG | Placebo | Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection). |
Timeline
- Start date
- 2017-11-01
- Primary completion
- 2019-07-31
- Completion
- 2019-08-27
- First posted
- 2018-01-17
- Last updated
- 2020-08-21
- Results posted
- 2020-08-21
Locations
70 sites across 7 countries: Czechia, Germany, Hungary, Poland, South Africa, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03400800. Inclusion in this directory is not an endorsement.