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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

NCT06386419 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Primary Hypercholesterolemia
  • Mixed Dyslipidemia

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06386419 on ClinicalTrials.gov