A Prospective Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,007
- 试验地点
- 1
- 主要终点
- Mean systolic blood pressure (SBP) reduction and mean diastolic blood pressure (DBP) reduction at month 3 and 6 from baseline
研究概览
简要总结
This is an observational, prospective, non-interventional, non-randomised, open label multicentric study planned to be conducted in 1000 subjects with mild to moderate primary hypertension in approximately 20 centres in Thailand. The purpose of this study is to examine the beneficial effects of combination of bisoprolol with hydrochlorothiazide available as Lodoz in treatment of Thai subjects with mild to moderate hypertension. The outcome of the study would also provide information on the optimal daily dosage schedule as well as adherence of Lodoz.
详细描述
Essential hypertension is a heterogenous multifactorial disease affecting large number of population. Monotherapy treatment in hypertension is often unable to achieve the desired blood pressure (BP) goals and subjects even remain at significant risk for developing cardiovascular disease. The use of combination therapy as first line treatment for hypertension provides a solution to the management problems related to hypertension. Among combination drugs, low dose combinations are useful tools in treating large segments of hypertensive subjects because of their several advantages, such as simplified dosage regimens, improve compliance and hypertensive control, decrease dose dependent side effects as well as reduce costs.
OBJECTIVES
Primary objective:
- To evaluate the efficacy of Lodoz therapy when used in routine clinical practice in subjects with mild to moderate essential hypertension.
Secondary objective:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Subjects diagnosed with mild to moderate essential hypertension
- •Subjects foreseen for Lodoz treatment for hypertension
- •Age ≥ 18 years
排除标准
- •Subjects treated with Lodoz before study initiation
- •Subjects who are pregnant
- •Subjects with any known contraindications to Lodoz based on local label
结局指标
主要结局
Mean systolic blood pressure (SBP) reduction and mean diastolic blood pressure (DBP) reduction at month 3 and 6 from baseline
时间窗: Baseline and until 6 months of treatment
次要结局
- Proportion of subjects having reached target BP level, regarding Thai Hypertension Society guideline(After 3 and 6 months of treatment)
- Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg)(After 3 and 6 months of treatment)
- Response rate for SBP (defined as ≥ 10 mm Hg or SBP < 140 mmHg)(After 3 and 6 months of treatment)