EUCTR2006-004533-15-DE进行中（未招募）不适用
Effect of 8 weeks oral Pentaerithrityltetranitrate on endothelial dysfunction in patients with coronary artery disease: A prospective, randomized, double-blind, placebo-controlled, monocentric clinical trial of phase IV - PENTA
Johannes Gutenberg-Universität Mainz, II. Med. Klinik (ausführende Stelle), Prof. Dr. T. Münzel0 个研究点目标入组 80 人开始时间: 2007年8月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects meeting all of the following criteria will be considered for admission to the trial:
- •-Men or women > 35 and < 80 years of age
- •-Documented clinically stable CAD with stable angina pectoris
- •-Ability of subject to understand the character and individual consequences of the clinical trial
- •-Written informed consent must be available before enrollment in the trial
- •-For women with childbearing potential, adequate contraception (oral contraceptives or intrauterine devices) is required.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following criteria will not be included in the trial:
- •-Clinical signs of congestive heart failure or left ventricular ejection fraction <30% (as demonstrated within the last 1 year by echocardiography, LV an-giography, MRI or radionuclide ventriculography, respectively)
- •-Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <110 mmHg)
- •-Initiation of any of the following medications within the last 8 weeks: Aspirin, statins, calcium antagonists, ACE-inhibitors or AT1 receptor blockers, hor-mone replacement therapy. Individuals who take any of these drugs longer than 8 weeks can be included in this trial.
- •-Use of Phosphodiesterase-5-inhibitors (Viagra®, Revatio®, Cialis®, Levitra®), dihydroergotamine and nitrates i.e. isosorbidemononitrate, isosorbidedinitrate, nitroglycerin, pentaerithrityltetranitrate or molsidomin within the last two weeks.
- •-Hemodynamically significant aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy (as demonstrated within the last year by echocardiogra-phy, invasive right/ left heart catheterization or MRI, respectively)
- •-Renal dysfunction (plasma creatinine (men: > 2.0 mg/dl, women: : > 1.8 mg/dl))
- •-Known hepatic disease or elevation of serum transaminases or gGT > 3x ULN (upper limit of normal range)
- •-WBC >16.000 or platelet count >500.000/µl or <75.000/µl
- •-Clinically overt hyperthyreodism
- •-Pregnancy and lactation
- •-Known intolerance to organic nitrates
- •-History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharma-ceutical form of the investigational medicinal product
- •-Other significant laboratory abnormalities that the investigator feels may com-promise the patient’s safety by participation in the study
- •-Participation in other clinical trials and observation period of competing trials, respectively
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