跳至主要内容
临床试验/NCT07084246
NCT07084246进行中(未招募)不适用

A Multi-center, Prospective, Non-intervention, Observational Study to Evaluate the Effectiveness and Safety of the Rozetel Tablet in Patients Who Had Undergone Percutaneous Coronary Intervention(PCI)

GC Biopharma Corp1 个研究点 分布在 1 个国家目标入组 1,563 人开始时间: 2023年6月7日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,563
试验地点
1
主要终点
The proportion of participants who meet the treatment goals for BP and LDL-C

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness and safety of the investigational drug on blood pressure and LDL cholesterol control during the observation period in patients who have undergone percutaneous coronary intervention (PCI) in actual clinical practice.

详细描述

This study is a multicenter, prospective, non-interventional observational study aimed at observing the efficacy and safety of the investigational product, a combination of telmisartan, rosuvastatin, and ezetimibe, in patients who have undergone percutaneous coronary intervention (PCI) for the control of blood pressure and lipid levels.

In actual clinical practice, patients aged 19 years and older who have undergone PCI and are receiving antihypertensive and dyslipidemia-related medications based on approved indications will be assessed for eligibility after receiving an explanation of the study and providing written consent, as determined by the investigator's judgment regarding the need for the investigational product.

Eligible participants according to the inclusion/exclusion criteria will receive the investigational product based on the approved indications (efficacy, dosage, precautions, etc.) after registration. Follow-up visits will be conducted at 24 weeks and 48 weeks (each ± 4 weeks) post-treatment to evaluate efficacy and safety.

All treatments, including drug administration and laboratory tests performed after the administration of the investigational product, will be conducted according to the investigator's medical judgment, independent of the participant's involvement in the study, and information to be collected in this observational study will continue for up to 48 weeks (± 4 weeks).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 19 years and older, both male and female.
  • Patients who have undergone percutaneous coronary intervention (PCI) and are receiving antihypertensive and dyslipidemia-related medications.
  • Individuals who require the administration of the investigational product based on the investigator's medical judgment in accordance with approved indications.
  • Individuals who can understand the information provided to them and are able to voluntarily sign the informed consent form.

排除标准

  • Individuals who fall under the contraindications for administration according to the approved indications of the investigational product.
  • Individuals who have a history of receiving the investigational product prior to participation in this study.
  • Individuals whom the investigator deems unsuitable for participation in this observational study for any other reason.

结局指标

主要结局

The proportion of participants who meet the treatment goals for BP and LDL-C

时间窗: From enrollment to the end of treatment at 24 weeks

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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