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 1-3 anti-hypertensives - SER100 in ISH

Serodus ASA0 个研究点目标入组 30 人开始时间: 2013年9月4日最近更新: 2014年8月5日

适应症

试验速览

暂无简介。

•Isolated Systolic Hypertension: 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 55-80 years (both inclusive) at screening
•Patients must be treated with 1-3 antihypertensives on unchanged doses for at least 30 days prior to screening visit. Intake of the underlying 1-3 anti-hypertensives must be witnessed by clinic staff prior to the qualifying ABPM.
•BMI <32 kg/m2
•Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•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 for any of
•o Creatinine
•o Bilirubin
•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

发起方