ASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 329
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This is a prospective, non-interventional, non comparative drug study. The efficacy of Quinapril in Asian population has been evaluated, but specifically in Indian patients the data is sparse. Data in a real world setting in a large population of Indian patients would shed more light on the safety, tolerability and effectiveness of Quinapril in the Indian population.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients already on therapy with Acupil® for a minimum period of 4 weeks, Evidence of a personally signed and dated informed consent document
排除标准
- •Patients having a Week 0 visit blood pressure reading of more than 180/110 mm of Hg will not be eligible to participate in the study.
- •Women of child bearing age, not willing to use contraceptives, will not be eligible for the study
- •Women using oral contraceptives will also not be included in the study
- •Patients who have received any drug other than Acupil® as the first prescribed antihypertensive would not be eligible for enrollment into the trial
- •Patients having any complication at Week 0 visit which would require more thorough investigations or who required more than one anti-hypertensive drug at the time of initiation of their therapy will not be included in the study
- •Patients having any contraindications as per the LPD of Acupil®
研究组 & 干预措施
quinapril
quinapril
干预措施: quinapril (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline to Week 52
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
次要结局
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 12(Baseline and Week 12)
- Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12(Baseline and Week 12)
- Change From Baseline in SBP at Week 52(Baseline and Week 52)
- Change From Baseline in DBP at Week 52(Baseline and Week 52)
- Change From Pre-treatment in SBP at Week 0(Pre-treatment and Week 0)
- Change From Pre-treatment in DBP at Week 0(Pre-treatment and Week 0)
- Number of Participants Achieving BP Goal at Week 12(Week 12)
- Number of Participants With Achievement of BP Goal at Week 52(Week 52)
- Duration of Monotherapy With Quinapril(Baseline up to week 52 or early termination)
- Mean Daily Dose of Study Medication(Baseline up to week 52 or early termination)
- Number of Participants With Preference for add-on Anti-hypertensive Therapy(Baseline up to week 52 or early termination)