NCT00553865已完成2 期
A 8-Week, Randomized, Double-blind, Parallel Designed, Phase II Multi-center Clinical Trial to Evaluate the Antihypertensive Efficacy and the Safety of OJP-2028 Tablets in Patients With the Uncomplicated Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline.
研究概览
简要总结
The purpose of this study is to determine the optimal dosage of the clinical trial which is evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.
详细描述
Evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women (Age 18-75 years)
- •Uncomplicated essential hypertension: Clinic sitting SiDBP between 90 and 109 mmHg after 2 week placebo run-in period
排除标准
- •Secondary hypertension
- •History and/or signs of cardiovascular complications (eg; myocardial infarction, unstable angina)
- •Pregnancy or lactation
- •Contraindications to the antihypertensive drugs to be used during the treatment period
研究组 & 干预措施
Group 1
Experimental
OJP-2028 1mg/day
干预措施: OJP-2028 (Drug)
Group 2
Experimental
OJP-2028 2mg/day
干预措施: OJP-2028 (Drug)
Group 3
Experimental
OJP-2028 4mg/day
干预措施: OJP-2028 (Drug)
Group 4
Placebo Comparator
Placebo
干预措施: OJP-2028 (Drug)
Group 5
Other
Reference drug
干预措施: OJP-2028 (Drug)
结局指标
主要结局
Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline.
时间窗: 8 weeks
次要结局
- Average SiSBP Differences of each group by comparison with the baseline.(8 weeks)
- Responder rate of each group by comparison with the baseline.(8 weeks)
- Average SiDBP and SiSBP Differences of each group by comparison with the baseline.(8 weeks)
研究者
研究点 (1)
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