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A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Sponsor: Novartis Pharmaceuticals
Summary
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.
Official title: A Real-world, Prospective, Multi-center, Open-label, Phase 4 Clinical Study to Evaluate the Safety and Effectiveness of Subcutaneous Injection of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2024-11-12
Completion Date
2026-02-27
Last Updated
2025-05-30
Healthy Volunteers
No
Interventions
inclisiran
Inclisiran 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
Locations (7)
Novartis Investigative Site
Bangalore, Karnataka, India
Novartis Investigative Site
Nagpur, Maharashtra, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Jaipur, Rajasthan, India
Novartis Investigative Site
Madurai, Tamil Nadu, India
Novartis Investigative Site
Vellore, Tamil Nadu, India
Novartis Investigative Site
Kolkata, West Bengal, India