NCT00522925已完成2 期
Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of a Novel Dual Angiotensin and Endothelin Receptor Antagonist (PS433540) in Subjects With Stage I and II 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
- 280
- 试验地点
- 15
- 主要终点
- Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure
研究概览
简要总结
The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 30 - 80 years
- •Mean seated Systolic Blood Pressure (SBP) ≥ 150 - ≤ 179 mmHg and mean seated DBP < 110 mmHg at two consecutive qualifying visits. The mean difference in SBP between the two consecutive qualifying visits must be ≤ 10 mmHg.
- •Mean daytime (8AM - 4PM) ambulatory SBP must be between ≥ 140 - ≤ 179 mmHg and mean daytime (8AM - 4PM) Diastolic Blood Pressure (DBP) ≤ 110 mmHg
- •Subjects must have a usual daytime schedule. Night shift workers are excluded from participation.
- •Women of child-bearing potential (WOCBP) and male subjects must use two reliable forms of contraception if sexually active. Alternatively, female subjects must be postmenopausal (for at least 1 year)
排除标准
- •Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of PS433540, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
- •Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or New York Heart Association (NYHA) class II-IV heart failure within the last 6 months.
- •Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
- •Subjects with diabetes mellitus (type I and type II).
研究组 & 干预措施
1
Placebo Comparator
Matching Placebo
干预措施: placebo (Drug)
2
Experimental
干预措施: PS433540 (Drug)
3
Experimental
干预措施: PS433540 (Drug)
结局指标
主要结局
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure
时间窗: 4 weeks of treatment with PS43540
次要结局
- Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure(4 weeks of treatment with PS43540)
- Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure(4 weeks of treatment with PS43540)
研究者
研究点 (15)
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