An Extension Trial of Inclisiran Compared to Evolocumab in Participants With Cardiovascular Disease and High Cholesterol
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atherosclerotic Cardiovascular Disease
- Familial Hypercholesterolemia
- Symptomatic Atherosclerosis
- Type2 Diabetes
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
ORION-3 is an open label, long term extension study with two arms: Group 1 (inclisiran only arm) will receive inclisiran only and Group 2 (switching arm) will receive an active comparator (evolocumab) followed by inclisiran. ORION-3 will be conducted in subjects with atherosclerotic cardiovascular d...
ORION-3 is an open label, long term extension study with two arms: Group 1 (inclisiran only arm) will receive inclisiran only and Group 2 (switching arm) will receive an active comparator (evolocumab) followed by inclisiran. ORION-3 will be conducted in subjects with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (eg, diabetes and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies who have completed study MDCO-PCS-15-01 (ORION-1) [NCT02597127], to evaluate the efficacy, safety, and tolerability of long-term dosing of inclisiran.
Tracking Information
- NCT #
- NCT03060577
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kausik Ray, MD Imperial College London
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