Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia
- Sponsor
- Amgen
- Study ID
- NCT03433755
- Phase
- PHASE3
- Status
- Terminated
Conditions
- Mixed Dyslipidemia
- Primary Hypercholesterolemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- evolocumab — DRUGEvolocumab will be administered per pre-filled auto-injector pen (AI/Pen). Participants will receive evolocumab (AMG 145) every 2 weeks or monthly subcutaneously.
- placebo — DRUGPlacebo will be administered per pre-filled auto-injector pen (AI/Pen). Participants will receive placebo every 2 weeks or monthly subcutaneously.
Study Details
This study is being done to learn more about evolocumab in Chinese people with primary hypercholesterolemia or mixed dyslipidemia. This study will see if evolocumab will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are also taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects.
Key Dates
- Start date
- May 9, 2019
- Status verified
- Mar 2023
- Primary completion
- Apr 24, 2020
- Completion
- May 9, 2020
Study Design
- Enrollment
- 259 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Placebo Q2WPlacebo subcutaneous (SC) Q2W for 12 weeks
- Placebo Comparator: Placebo QMPlacebo SC QM for 12 weeks
- Experimental: Evolocumab 140 mg Q2WEvolocumab 140 mg SC Q2W for 12 weeks
- Experimental: Evolocumab 420 mg QMEvolocumab 420 mg SC QM for 12 weeks
Primary Outcome Measure
Co-Primary Endpoint: Percent Change From Baseline in LDL-C: Mean of Weeks 10 and 12 [ Time Frame: Baseline, Weeks 10 and 12 ]