NCT01260857撤回不适用
An Open Label, Observational, Post Marketing Surveillance Study To Assess The Safety And Efficacy Of The Spironolactone Plus Hydroflumethiazide (Aldazide) In The Treatment Of Filipino Patients With Stage 1 To 2 Hypertension
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Report of Adverse Events occurence (Safety)
研究概览
简要总结
Aldazide 25 mg OD will be given to Filipino hypertensive patients, and there will be 2 follow-up visits on week 4 and week 8 to monitor for safety and efficacy as primary and secondary outcomes, respectively.
详细描述
Prospective, non-interventional non-probability sampling
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >/= 18 years old with Stage 1 or 2 hypertension not controlled by monotherapy or by a combination of anti-hypertensives without any diuretic yet.
排除标准
- •Pregnant or lactating women, with hypersensitivity to Aldazide, patients with resistant hypertension not controlled by a combination therapy with a diuretic in their regimen
结局指标
主要结局
Report of Adverse Events occurence (Safety)
时间窗: 8 weeks
次要结局
- Systolic BP in mmHg(8 weeks)
- Diastolic BP in mmHg(8 weeks)
- % of patients reaching BP goal of <140/90 mmHg and <130/80 mmHg for DM and proteinuric patients(8 weeks)
研究者
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