A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT06386419
- Phase
- PHASE4
- Status
- Completed
Conditions
- Mixed Dyslipidemia
- Primary Hypercholesterolemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- inclisiran — DRUGInclisiran sodium 300 mg SC. Three single doses of inclisiran sodium will be administered to the participants on Day 1, Day 90, and Day 270, respectively
Study Details
This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium.
Key Dates
- Start date
- Nov 12, 2024
- Status verified
- Apr 2026
- Primary completion
- Jan 13, 2026
- Completion
- Jan 13, 2026
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: inclisiran300 mg inclisiran sodium equivalent to 284 mg inclisiran administered as a single SC injection
Primary Outcome Measure
Incidence and type of treatment-emergent adverse events (TEAEs) [ Time Frame: 10 months (300 days) ]