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NCT06386419CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 23 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
65 (actual)
First submitted
23 Apr 2024
Start date
12 Nov 2024
Primary completion date
13 Jan 2026
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT06386419

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 65
  • From 12 Nov 2024 to the primary completion date, 13 Jan 2026
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Lab values

  • Participants who have previous exposure to inclisiran sodium.

Other

  • Pregnant or nursing (lactating) women.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BangaloreIndiaUnknown status
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BelagaviIndiaUnknown status
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JaipurIndiaUnknown status
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KolkataIndiaUnknown status
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MaduraiIndiaUnknown status
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MumbaiIndiaUnknown status
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NagpurIndiaUnknown status
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Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
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Coordinator of this site? Confirm its status
VelloreIndiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.