ISRCTN14741769已完成4 期
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
Johannes Gutenberg University of Mainz (Germany)0 个研究点目标入组 80 人开始时间: 2007年6月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
2010 results in https://www.ncbi.nlm.nih.gov/pubmed/19957087 (added 07/01/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men or women > 35 and < 80 years of age
- •2. Documented clinically stable CAD with stable angina pectoris
- •3. Ability of subject to understand the character and individual consequences of the clinical trial
- •4. Written informed consent must be available before enrollment in the trial
- •5. For women with childbearing potential, adequate contraception (oral contraceptives or intrauterine devices) is required
排除标准
- •1. Clinical signs of congestive heart failure or left ventricular ejection fraction <30% (as demonstrated within the last 1 year by echocardiography, Left Ventricular [LV] angiography, Magnetic Resonance Imaging [MRI] or radionuclide ventriculography, respectively)
- •2. Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <110 mmHg)
- •3. Initiation of any of the following medications within the last 8 weeks: aspirin, statins, calcium antagonists, Angiotensin Converting Enzyme (ACE)-inhibitors or AT1 receptor blockers, hormone replacement therapy. Individuals who take any of these drugs longer than 8 weeks can be included in this trial.
- •4. 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.
- •5. Hemodynamically significant aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy (as demonstrated within the last year by echocardiography, invasive right/ left heart catherterization or MRI, respectively)
- •6. Renal dysfunction (plasma creatinine [men: > 2.0 mg/dl, women: > 1.8 mg/dl])
- •7. Known hepatic disease or elevation of serum transaminases or gGT > 3 x Upper Limit of Normal range (ULN)
- •8. White Blood Cells (WBC) >16.000 or platelet count >500.000/µl or <75.000/µl
- •9. Clinically overt hyperthyreodism
- •10. Pregnancy and lactation
- •11. Known intolerance to organic nitrates
- •12. Known lactose intolerance
- •13. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- •14. Other significant laboratory abnormalities that the investigator feels may compromise the patient's safety by participation in the study
- •15. In other clinical trials and observation period of competing trials, respectively
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