Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia: a Multi-center-database Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- The rate of change in LDL-C
研究概览
简要总结
This study is a large-scale, prospective, multi-center, and non-interventional observation study to observe blood pressure and blood lipid changes and safety during administration of olomax tablets for 24 weeks in hypertensive patients with dyslipidemia.
详细描述
In this study, investigator will evaluate subjects' clinical performance in actual care. Laboratory test results such as demographic information and medical treatment, blood pressure, blood lipid test, and liver function test conducted at the start date of Olomax tablet administration and subsequent 24 weeks (± 8 weeks) will be collected. In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Adult aged 19 or older at the time of the baseline visit.
- •A patient with hypertension and dyslipidemia who is scheduled to administer olomax tablet according to investigator's medical judgement.
- •Patients who were previously taking more than two tablets of a single drug, low-density lipoprotein-cholesterol (LDL-C)
- •Patients who were previously only taking blood pressure-lowering drugs and did not take LDL-C-lowering drugs, but who need to take additional LDL-C-lowering drugs at the discretion of the researcher
- •Patients who were previously taking LDL-C lowering agents and did not take blood pressure lowering agents, but who need to take additional blood pressure lowering agents according to the researcher's judgment
- •Patients who have not previously taken both a blood pressure drop and an LDL-C drop but need additional simultaneous use at the discretion of the researcher
- •A person who can understand the information provided to him/her and may voluntarily sign a written consent form
排除标准
- •A person who falls under the prohibition of administration according to the permission for olomax tablet
- •A person who has a history of administering olomax tablets before participating in this study
- •In addition to the above, a person that the investigator thinks he/she is not suitable for participating in this observation study;
研究组 & 干预措施
patients with hypertension and dislipidemia
received olomax tablet as treatment.
干预措施: Olmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca (Drug)
结局指标
主要结局
The rate of change in LDL-C
时间窗: at 24 weeks
The rate of change in LDL-C at 12 weeks from baseline
The amount of change in LDL-C
时间窗: at 24 weeks
The amount of change in LDL-C at 24 weeks from baseline
次要结局
- The rate of change in LDL-C(at 12 weeks)
- The amount of change in LDL-C(at 12 weeks)
- The amount of change in SBP(Systolic Blood Pressure)(24 weeks)
- The rate of change in SBP(Systolic Blood Pressure)(24 weeks)
- The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)(24 weeks)
- The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG)(24 weeks)
- Percentage of subjects who reached LDL-C target(24 weeks)