CompletedPhase 4

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

India65 participantsStarted 2024-11-12

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Male and female Indian participants aged ≥18 years or older.
✓. Participants for whom the treating physician prescribes treatment with inclisiran sodium in adherence with the India PI i.e., patients who are diagnosed with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:
✓. in combination with a statin or statin with other LLTs in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
✓. alone or in combination with other LLTs in patients who are intolerant to statins or for whom a statin is contraindicated.
✓. Participants on LLTs should be on a stable dose for ≥30 days before the first dose administration of the study treatment.

Exclusion criteria

✕. Any surgical and/or medical condition, which in the opinion of the treating physician, may place the participant at higher risk of his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
✕. Participants who have previous exposure to inclisiran sodium.
✕. Pregnant or nursing (lactating) women.

What they're measuring

Incidence and type of treatment-emergent adverse events (TEAEs)

Timeframe: 10 months (300 days)

Trial details

NCT IDNCT06386419

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-13

View on ClinicalTrials.gov More Primary Hypercholesterolemia trials