NCT01987284已完成2 期
A Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study Assessing the Safety, Tolerability and Efficacy of SER100 10 mg s.c. Twice Daily for 2 Days in Patients With Isolated Systolic Hypertension Insufficiently Treated With One or More Anti-hypertensives.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Serodus AS
- 入组人数
- 17
- 试验地点
- 7
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Isolated Systolic Hypertension (ISH)is the dominating hypertensive disease in elderly people. Much attention has recently been drawn to the strong relationship between the systolic blood pressure and cardiovascular morbidity.
In previous clinical studies carried out in individuals with normal blood pressure at baseline SER100 decreased primarily the systolic blood pressure. It is hypothesized that the effect on systolic blood pressure in hypertensive patients will be larger or equal to the fall seen in normotensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean systolic blood pressure ≥ 150 mmHg and mean diastolic blood pressure < 90 mmHg - as determined by daytime continuous ambulatory blood pressure measurement (ABPM)
- •Male or female
- •Age 50-80 years (both inclusive) at screening
- •Patients must be on stable doses with one or more antihypertensives
- •BMI <32 kg/m2
- •Written informed consent
排除标准
- •Acute myocardial infarction in the last 6 months before screening
- •Stroke in the last 6 months before screening
- •Uncompensated heart failure (NYHA Class IV)
- •Angina pectoris with an anticipated need for administration of short-acting nitrates
- •Known, severe sleep apnoea
- •Abnormal laboratory values (i.e. > 2 x upper normal limit) at screening
- •Subjects working night shifts (11 PM to 7 AM)
- •Participation in any other clinical trial with an investigational medicinal product or device within 1 month prior to randomisation.
- •Subjects with upper arm circumference ≤24 cm or ≥ 42 cm.
- •Any general condition, serious disease or current evidence of any mental or physical disorder or collaboration attitude (e.g. dementia, substance abuse) which, in the judgment of the investigator makes the subject unsuitable for enrollment, and/or may interfere with the study evaluations or affect subject's safety and/or may cause risk for poor protocol compliance
- •Pregnant or lactating women.
- •Female subjects of childbearing potential, or male subjects whose female partner (unless post-menopausal for 1 year or surgically sterile) is unwilling to use adequate contraceptive measures throughout the duration of the study
研究组 & 干预措施
SER100
Experimental
SER100 10 mg s.c. twice daily
干预措施: SER100 (Drug)
SER100
Experimental
SER100 10 mg s.c. twice daily
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo administered s.c. twice daily
干预措施: SER100 (Drug)
Placebo
Placebo Comparator
Placebo administered s.c. twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 4 weeks
次要结局
- Change from baseline in systolic blood pressure(Up to 4 weeks)
研究者
研究点 (7)
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