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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 12
- 主要终点
- The primary endpoint of the study is the incidence and characteristics of TEAEs during the 10
研究概览
简要总结
The purpose of this study is to evaluate the post-marketing safety and effectiveness of inclisiran
sodium SC injections in Indian patients with a diagnosis of primary hypercholesterolemia
(heterozygous familial and non-familial) or mixed dyslipidemia receiving a statin or statin with
other LLTs and are either unable to reach LDL-C goals with the maximum tolerated dose of a
statin, or are statin-intolerant, or for whom a statin is contraindicated.
ï‚· The study duration will be of 300 days. The total study duration may vary depending on the
visit windows allowed for the treatment period and EOS visit.
ï‚· The treatment duration will be up to Day 270.
ï‚· There will be a total of 4 site visits for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants eligible for inclusion sodium in this study must meet all of the following criteria:
- •Signed informed consent must be obtained prior to participation in the study.
- •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 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.
- •Participants on LLTs should be on a stable dose for ≥30 days before the first dose administration of the study treatment.
排除标准
- •Participants meeting any of the following criteria are not eligible for inclusion in this study:
- •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.
结局指标
主要结局
The primary endpoint of the study is the incidence and characteristics of TEAEs during the 10
时间窗: Baseline to day 300
month (300-day) study period with inclisiran sodium.
时间窗: Baseline to day 300
次要结局
- The secondary objectives of the study are:(ï‚· To evaluate the effectiveness of inclisiran sodium in terms of change in LDL-C levels from)
研究者
Pallavi Kawatra
Novartis Healthcare Private Limited