ISRCTN06278310已完成3 期
ebivolol or Metoprolol in Arterial Occlusive Disease: A double-blind, randomised controlled trial
Berlin-Chemie (Germany) (part of Menarini Group [Italy])0 个研究点目标入组 128 人开始时间: 2010年6月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male patients 30 years to 80 years or female postmenopausal patients up to 80 years
- •2. Arterial occlusive disease Fontaine´s stage II A or B
- •3. Stage I hypertension according to Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC) with or without hypertensive treatment
排除标准
- •1. Arterial occlusive disease with rest pain or leg ulcer
- •2. Any concomitant disease limiting the exercise capacity of the patient
- •3. Poorly controlled diabetes HbA1c > 10%
- •4. Acute myocardial infarction during the last 6 month
- •5. Treatment with COX-2 inhibitors
- •6. Previous treatment with nebivolol or carvedilol
- •7. Concomitant treatment with drugs that may influence endothelial function
- •8. Contraindication to the study drug
- •9. Participation in an other clinical trail the last 6 month
- •10. Acute pathologic haemorrhage
- •11. Known hyperthyoidism
- •12. Psychiatric diseases
- •13. Known hypersensivity to nebivolol or metoprolol
- •14. Prior or active malignancy in the previous 5 years
- •15. History of drug or alcohol abuse
- •16. Unwilling or unable to provide informed consent
研究者
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EBIVOLOL OR METOPROLOL IN ARTERIAL OCCLUSIVE DISEASEA DOUBLE-BLIND, RANDOMISED CLINICALDeutscher Titel: Nebivolol im Vergleich zu Metoprolol bei peripherer arterieller VerschlusskrankheitEine randomisierte, doppel-blinde klinische Studie - NORMAIntermittent claudication (peripheral arterial disease) Fontaine’s stage II Deutsch: Periphere arterielle Verschlusskrankheit, Fontaine Staidum IIMedDRA version: 8.0Level: LLTClassification code 10062585EUCTR2005-003583-31-DEBerlin-Chemie AG160
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