PMS Study of MicardisPlus Tablet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,901
- 试验地点
- 74
- 主要终点
- Unexpected Adverse Events
研究概览
简要总结
This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:
- Unexpected adverse drug reactions (especially, serious adverse events (SAEs))
- Frequency of incidence and its change in adverse events (AEs)
- Factors on the safety profile of the study drug
- Factors on the efficacy profile of the study drug
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with essential hypertension
排除标准
- •patients who took Micardis Plus before participating in this PMS study
结局指标
主要结局
Unexpected Adverse Events
时间窗: Up to 6 years
Occurrence status of unexpected adverse events
Frequency of Adverse Events
时间窗: Up to 6 years
Change From Baseline in SBP (Systolic Blood Pressure) at Week 2
时间窗: Baseline and End of Study
Effect on decrease in systolic blood pressure
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2
时间窗: Baseline and End of Study
Effect on decrease in diastolic blood pressure
Effective Rate
时间窗: Baseline and End of Study
Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows: Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved) Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed)
次要结局
- Gender Factors Affecting the Safety Profile(Up to 6 years)
- Age Factors Affecting the Safety Profile(Up to 6 years)
- Proportion of Geriatric Population Factor Affecting the Safety Profile(Up to 6 years)
- Treatment Type Factors Affecting the Safety Profile(Up to 6 years)
- Medical History Factors Affecting the Safety Profile(Up to 6 years)
- Concomitant Disease Factors Affecting the Safety Profile(Up to 6 years)
- Medical History Factors Affecting the Efficacy Profile(Baseline and End of Study)
- Previous Medication Factors Affecting the Efficacy Profile(Baseline and End of Study)
- Baseline Severity of Hypertension Factors Affecting the Efficacy Profile(Baseline and End of Study)
- Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile(Baseline and End of Study)