Status:
COMPLETED
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, o...
Detailed Description
The expected duration of the participants' involvement in the study was approximately 374 days which included screening (up to 14 days), Day 1 study drug administration, two additional injections on D...
Eligibility Criteria
Inclusion
- Participants with history of CAD or participants categorized in 'high risk' by Japan Atherosclerosis Society (JAS) 2017 guidelines or participants with heterozygous familial hypercholesterolemia (HeFH)
- As per the JAS 2017 guideline, participants not meeting the LDL-C management targets.
- Participants on statins should be receiving a maximally tolerated dose.
- Participants not receiving statins must have documented evidence of intolerance to at least one statin.
- The lipid-lowering therapy should have remained stable for ≥ 30 days before screening with no planned medication/ dose change until Day 180
Exclusion
- Participants diagnosed with homozygous familial hypercholesterolemia (HoFH).
- Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.
- New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction \<25%.
- Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation.
- Uncontrolled hypertension: systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg prior to randomization despite antihypertensive therapy.
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), \>3x the upper limit of normal (ULN), or total bilirubin \>2x ULN at screening.
- Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2022
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT04666298
Start Date
January 29 2021
End Date
October 19 2022
Last Update
June 20 2024
Active Locations (42)
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1
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
2
Novartis Investigative Site
Matsudo, Chiba, Japan, 271 0077
3
Novartis Investigative Site
Itoshima, Fukuoka, Japan, 819-1104
4
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 800-0057