AN OPEN LABEL, NON-INTERVENTIONAL STUDY OF THE SAFETY, TOLERABILITY, AND EFFICACY OF AMLODIPINE AND OLMESARTAN MEDOXOMIL (NORMETECTM) IN FILIPINO PATIENTS WITH HYPERTENSION: A POST MARKETING SURVEILLANCE STUDY
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 615
- 试验地点
- 16
- 主要终点
- Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Filipino hypertensive subjects ages 18-65 years old whether naive or currently taking any other anti-hypertensive or those on monotherapy using CCBs or ARBs whom they want to shift on a fixed dose combination drug
排除标准
- •Patients with contraindications to any of the component of the fixed drug (amlodipine or olmesartan medoxomil) or with malignant or secondary hypertension
研究组 & 干预措施
Filipino Hypertensive patients
Male and Female, 18 to 65 year old Filipino hypertensive patients prescribed by their doctors with Normetec
干预措施: Amlodipine + Olmesartan medoxomil (Drug)
结局指标
主要结局
Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)
时间窗: Baseline, Week 12
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 28 days after last study drug administration (Week 12)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration (Week 12) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
次要结局
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF(Baseline, Week 4, Week 8, Week 12)
- Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF(Baseline, Week 12)