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ACTIVE NOT RECRUITING
NCT06386419
PHASE4

A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

DRUG

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