A Prospective, Randomized Double-blind Parallel Group Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects With Mild to Moderate Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 665
- 试验地点
- 38
- 主要终点
- Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline
研究概览
简要总结
Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Eprosartan
Eprosartan + Placebo Eprosartan Mesylate
干预措施: Eprosartan (Drug)
Eprosartan
Eprosartan + Placebo Eprosartan Mesylate
干预措施: Placebo Eprosartan mesylate (Drug)
Eprosartan Mesylate
Eprosartan Mesylate + Placebo Eprosartan
干预措施: Eprosartan Mesylate (Drug)
Eprosartan Mesylate
Eprosartan Mesylate + Placebo Eprosartan
干预措施: Placebo Eprosartan (Drug)
结局指标
主要结局
Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline
时间窗: 8 weeks
Change from baseline of diastolic blood pressure (DBP), sitting
次要结局
未报告次要终点