A Non-interventional, Multi Center, Prospective Observational Study to Evaluate the Effect of Improving Systolic Blood Pressure and Low-density Lipoprotein Cholesterol Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab. in Patients With Essential Hypertension and Dyslipidemia.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,845
- 试验地点
- 1
- 主要终点
- absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Olostar Tablet on blood pressure and lipid profiles, obtain safety-related information for subgroups that failed to participate in the clinical trials, and to evaluate variables that affect treatment effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •men and women over the age of 19
- •Patients who signed a written consent form to participate in the study
- •Patients who are eligible for Olostar tablet prescription according to domestic permission
排除标准
- •A person who falls under "
- •Do not administer to the following patients" among the precautions for use in the user manual
- •Patients in hospital (hospitals only; nursing care facilities can be recruited)
- •A person who has been administered the study target drug or is being administered at the time of recruitment within 6 months based on the date of the study contract
研究组 & 干预措施
Experimental/ Olostar Tablet
Eligible Subjects who received Olostar Tablet treatment for 24 weeks. Dosage: 10/5mg, 10/10mg, 20/5mg, 20/10mg, 20/20mg, 40/10mg, 40/20mg
干预措施: Rosuvastatin, Olmesartan Medoxomil (Drug)
结局指标
主要结局
absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C)
时间窗: 24 weeks
Evaluation of absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C) compared to baseline
absolute change and rate of change in systolic and diastolic blood pressure
时间窗: 24 weeks
Evaluation of absolute change and rate of change in systolic and diastolic blood pressure compared to baseline
次要结局
- Blood pressure treatment goal achievement rate(24 weeks)
- Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg(24 weeks)
- Olostar tablet compliance(24 weeks)
- Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals(24 weeks)
- LDL-C treatment goal achievement rate(24 weeks)
- Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.)(24 weeks)
- Evaluation of variables affecting compliance and persistence with Olostar tablets(24 weeks)
- Evaluation of convenience of taking Olostar tablets(24 weeks)
- Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets(24 weeks)
- Olostar tablet dose change(24 weeks)
- Olostar Tablet persistence(24 weeks)
- Evaluation of compliance(24 weeks)
- Assessment of Variables Influencing the Simultaneous Achievement of General(24 weeks)