drugset / Trial / NCT06386419

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

NCT06386419

Phase 4 Completed 65 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-11-12
Primary completion
2026-01-13
Completion
2026-01-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Inclisiran Small interfering RNA (siRNA) 300 mg Subcutaneous