A Multi-center, Prospective, Observational Study to Evaluate the Therapeutic Effectiveness and Safety of Olomax Tab. for Patients With Hypertension and Dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,450
- 试验地点
- 1
- 主要终点
- LDL-C treatment goal achievement rate
研究概览
简要总结
Throughout this study, the efficacy and safety information of Olomax tablets will be collected from 24 weeks to 48 weeks(+8 weeks) The Data collection point is baseline, at more than 24 weeks, at more than 48 weeks(+8 weeks).
详细描述
The study will start after investigator determines the administration of Olomax tablets based on the investigator's judgement and obtaining informed consent from the subject during subject's daily visit.
The dose of the Olomax tablet for each subject will be determined based on efficacy and drug resistance according to the subject's previous drug administration.
Throughout this study, the efficacy and safety information of Olomax tablets will be collected from 24 weeks to 48 weeks(+8 weeks) The Data collection point is baseline, at more than 24 weeks, at more than 48 weeks(+8 weeks).
Efficacy of Olomax tablets will be evaluated based on the data collected from more than 24 weeks to 48 weeks(+8 weeks) from the baseline visit. Safety of Olomax tablets will be evaluated based on the adverse events collected during the study peroid.
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
- •Adults over the age of 19
- •Patients eligible for Olomax Tab. prescription in accordance with the approved product manual in Korea
- •Patients who are determined to prescribe Olomax Tab. at the discretion of the investigators.
- •Antihypertensive agent: Do not include more than 3 agents.
- •Anti-abnormal lipidemia: Do not include more than 2 agents.
- •Subjects who are already administered beta blocker (BB) or diuretics due to other diseases such as angina, not for the purpose of treating hypertension may be included.
- •Consent on the use of information by the patient
排除标准
- •Patients who have already administered olomax tablets.
- •Subject who fall under ' Do not administer to the following patients' in the precautions for use
- •A patient who does not meet the inclusion/exclusion criteria participates
- •The patient withdraws consent for the study
- •The administration of the study drug is discontinued
- •It is impossible to follow up during the observation period
- •The investigator determines that it is no longer feasible to continue the study
结局指标
主要结局
LDL-C treatment goal achievement rate
时间窗: more than 24 weeks
LDL-C treatment goal achievement rate: The percentage of patients observed for more than 24 weeks compared to the baseline whose LDL-C reached the target level
Blood pressure treatment goal achievement rate
时间窗: more than 24 weeks
Blood pressure treatment goal achievement rate: The percentage of patients observed for more than 24 weeks compared to the baseline whose blood pressure reached the target value
次要结局
- The proportion of patients who have reached the treatment goal at baseline and maintain the change in blood pressure and treatment goal(24 to 48 weeks)
- the percentage of patients maintaining the treatment goal and the amount of change in blood pressure(24 to 48 weeks)
- For patients who did not reach the treatment goal at baseline, change in LDL-C, rate of reaching the treatment goal(24 to 48 weeks)
- Among patients who reached the treatment goal at baseline, the change in LDL-C, the proportion of patients maintaining the treatment goal(24 to 48 weeks)
- the rate and amount of change in both blood pressure and LDL-C(more than 24 weeks)
- Change in blood pressure(24 to 48 weeks)
- Patients who did not reach the treatment goal at baseline, change in blood pressure and rate of reaching the treatment goal(24 to 48 weeks)
- For patients who did not reach the treatment goal at baseline, the amount of change in blood pressure and the rate of reaching the treatment goal(24 to 48 weeks)
- Change in LDL-C(24 to 48 weeks)
- Among patients who reached the treatment goal at baseline, the change in LDL-C , the proportion of eligible patients maintaining the treatment goal(24 to 48 weeks)
- Change amount and rate of change in lipid variables(24 to 48 weeks)
- hsCRP change(more than 24 weeks)
- change in carotid intima-media thickening (CIMT) value(more than 24 weeks)
- Change in Framingham Risk Score (FRS)(more than 24 weeks)