EFFECTS OF NEBIVOLOL ON THE WALKING ABILITY IN PATIENTS WITH ESSENTIAL HYPERTENSION AND PERIPHERAL ARTERIAL DISEASE INTERMITTENT CLAUDICATIO

Berlin-Chemie Menarini0 个研究点目标入组 200 人2006年2月21日

适应症ESSENTIAL HYPERTENSION AND PERIPHERAL ARTERIAL DISEASE INTERMITTENT CLAUDICATIO

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: ESSENTIAL HYPERTENSION AND PERIPHERAL ARTERIAL DISEASE INTERMITTENT CLAUDICATIO
发起方: Berlin-Chemie Menarini
入组人数: 200
状态: 进行中（未招募）
最后更新: 14年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2006年2月21日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Berlin-Chemie Menarini

入排标准

入选标准

•Screening inclusion criteria
•2\. \=40 years to 75 years
•3\.PAD Fontaine’s stage II with:
•a history of typical intermittent claudication for at least 6 months with documented lesions by duplex sonography or angiography within the last 36 months prior to inclusion,
•actual proven PAD by objective means such as haemodynamics and non\-invasive imaging or angiography,
•a history (\> 1 month before study inclusion) of previous peripheral (lower extremity) vascular intervention such as surgical endarterectomy, by pass grafting or aortic abdominal aneurysm repair or PTA with or without stenting is allowed,
•an ankle\-brachial pressure index (ABPI) of the worse leg \< 0\.90,
•advice on smoking cessation has been given and documented prior to inclusion in the trial; smoking habit is stable for at least 3 months prior to inclusion in the trial.
•4\.No further improvement in previous exercise training or failure of previous tried exercise training or experience of patient’s lack of compliance regarding exercise training or patients unable to perform exercise training. Walking training must be applied during the trial.
•5\.Hypertension according to the Joint National Committee on Hypertension (JNC) (systolic blood pressure (SBP) 140\-159 mmHg and/or diastolic blood pressure (DBP) 90\-99 mmHg) with or without treatment with antihypertensive drugs

排除标准

•1\.PAD with rest pain or leg ulcer or gangrene (Fontaine stage III –IV resp. critical limb ischemia (CLI): systolic ankle pressure \= 50 mmHg or systolic toe pressure \= 30
•mmHg or transcutaneous partial oxygen pressure (tcpO2\) \= 10 %)
•2\.Any concomitant disease limiting the exercise capacity of the patient (e.g. but not limited to: angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorder)
•3\.Standardized exercise training during the study (e.g. supervised physical group\-training or individual training) or walking exercises during the study exceeding the all\-day habits of the patient as compared to the patient’s habits prior to study inclusion
•4\.Poorly controlled diabetes mellitus (HbA1c \> 8\.5%)
•5\.Orthopedic, neurological or pulmonary concomitant diseases, which limit or may limit the walking distance.
•6\.Anticipated need for limb, coronary, or carotid vascular surgery or angioplasty during the trial
•7\.Previous treatment within the last 4 weeks prior to screening or concomitant treatment with rheologic agents (including herbal substances like Ginkgo Biloba (or Padma28\) ) or substances that may influence the progression of the PAD or the walking distances except for the trial medication and the background medication
•8\.Treatment with alpha\-blockers or vasodilators as prostaglandin E1, prostaglandin I2 analoga, pentoxiphyllin, naftidrofuryl and buflomedil \< 3 month stable before Visit 1\.
•9\.Regular use of analgesics with anti\-inflammatory potential, i.e. NSAIDs. Treatment on demand and ? 7 days, e.g. for headache is allowed.