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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

CompletedPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Primary Hypercholesterolemia, Mixed Dyslipidemia

Interventions: inclisiran

Countries: India

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Male and female Indian participants aged ≥18 years or older.
2. 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:

   1. 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
   2. alone or in combination with other LLTs in patients who are intolerant to statins or for whom a statin is contraindicated.
3. Participants on LLTs should be on a stable dose for ≥30 days before the first dose administration of the study treatment.

Exclusion Criteria:

1. 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.
2. Participants who have previous exposure to inclisiran sodium.
3. Pregnant or nursing (lactating) women.

Locations (9)

Bangalore, Karnataka, India
Belagavi, Karnataka, India
Mumbai, Maharashtra, India
Nagpur, Maharashtra, India
New Delhi, National Capital Territory of Delhi, India
Jaipur, Rajasthan, India
Madurai, Tamil Nadu, India
Vellore, Tamil Nadu, India
Kolkata, West Bengal, India