Health Condition 1: E780- Pure hypercholesterolemia
Conditions
Interventions
Intervention1: Inclisiran SC injection: A real-world, prospective, multi-center, open-label, phase 4
clinical study to evaluate the safety and effectiveness of
subcutaneous injection of inclisiran sod
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion sodium in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male and female Indian participants aged >=18 years or older. 3. Participants for whom the treating physician prescribes treatment with inclisiran sodium in adherence with the India Prescribing Information (PI) i.e., patients who are diagnosed with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet: a. 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 b. alone or in combination with other LLTs in patients who are statin-intolerant, or for whom a statin is contraindicated. 4. Participants on LLTs should be on a stable dose for >=30 days before the first dose administration of the study treatment.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the incidence and characteristics of TEAEs during the 10 month (300-day) study period with inclisiran sodium.Timepoint: Baseline to day 300 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the study are: ï?· To evaluate the effectiveness of inclisiran sodium in terms of change in LDL-C levels from baseline to Day 300. ï?· To determine the proportion of participants achieving LDL-C goals on Day 300. ï?· To evaluate the effectiveness of inclisiran sodium in reducing other lipid markers from baseline to Day 300.Timepoint: Baseline to day 300 | — |
Countries
India
Contacts
Public ContactPallavi Kawatra
Novartis Healthcare Private Limited
Outcome results
None listed