EUCTR2005-001970-29-CZ进行中（未招募）不适用
Multinational, prospective, randomized, double-blind, placebo-controlled, parallel groups study to assess the efficacy and safety of Prostaglandin E1 in subjects with circulatory disturbance of a limb - ESPECIA
Schwarz Pharma Deutschland GmbH0 个研究点目标入组 500 人开始时间: 2005年9月26日最近更新:
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
- 500
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
- •1. Subject is informed and given ample time and opportunity to think about her/his
- •participation and has given her/his written informed consent.
- •2. Subject is willing and able to comply with all trial requirements.
- •3. Male or female subjects of at least 45 years of age.
- •4. Non-diabetic as well as diabetic subjects (type II) with macro-angiopathy, each
- •with proven PAOD and presenting up to 2 ischemic skin lesions for more than 2
- •weeks with or without rest pain (PAOD Fontaine stage IV). Skin lesions may not
- •exceed an area of 6 cm2 and at least one lesion has to be larger than 1 cm2.
- •5. Subject has a last complete angiography (conventional or better) of the pelvis,
- •the thigh and the calf performed within one month of inclusion.
- •6. Systolic ankle pressure =70 mmHg in subjects without media sclerosis of the
- •lower limb artery or systolic big toe pressure =50 mmHg in diabetics with media
- •sclerosis of the lower limb artery.
- •7. Subject’s life expectancy is =180 days (investigator’s judgment).
- •8. Subject is not in the position to be primarily revascularized (ie, subjects for whom
- •revascularization will in the investigator’s opinion most probably only bring
- •incomplete perfusion, or subjects with a high risk of failure/amputation or any
- •other safety risk associated with the revascularization procedure. The
- •investigator’s opinion should be in agreement with surgeons/interventional
- •radiologists present at the location) OR Subject is in the position to be primarily
- •revascularized but refuses surgery (refusal will be documented and signed by the
- •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
- •1. Subject has an imminent or foreseeable amputation.
- •2. Subject has a major amputation on the affected extremity.
- •3. Subject has previously participated in this trial or subject has previously been
- •assigned to treatment in a trial of the drug under investigation in this trial.
- •4. Subject has participated in another trial of an investigational drug or a medical
- •device within the last 30 days or is currently participating in another trial of an
- •investigational drug or a medical device.
- •5. Subject has a history of chronic alcohol or drug abuse.
- •6. Subject has any medical or psychiatric condition that in the opinion of the
- •investigator can jeopardize or would compromise the subject’s ability to
- •participate in this trial.
- •7. Subject has a known hypersensitivity to any components of the investigational
- •product(s) as stated in this protocol.
- •8. Subject has more than two ischemic ulcerations (persistent, non-healing
- •ulcerations or gangrene).
- •9. Subject presents at least one ulcer =6 cm2, both ulcers =1 cm2 or at least one
- •ulcer affecting the bone or tendons.
- •10. Subject has acute ischemia and peripheral vascular disorders of inflammatory or
- •immunologic origin.
- •11. Subject has venous ulcers.
- •12. Subject has neuropathic ulcers.
- •13. Subject has Buerger's disease.
- •14. Subject has septic gangrene.
- •15. Subject concomitantly uses vasoactive medication (eg, naftidrofuryl,
- •pentoxifylline, buflomedil, cilostazol) or other prostaglandins.
- •16. Subject was treated with prostanoids within 3 months prior to inclusion in this
- •17. Subject presents laboratory values outside the normal range unless considered
- •not clinically relevant by the investigator.
- •18. Subject had surgical or other interventional measures performed on the affected
- •extremity within 3 months prior to commencement of study drug treatment.
- •19. Subject had a myocardial infarction within 6 months prior to commencement of
- •study drug treatment.
- •20. Subject with mental or psychiatric conditions which suggest inability to
- •understand written and verbal instructions, in particular regarding the risks and
- •inconveniences he/she will be exposed to as a result of their participation in the
- •21. Subject has a known or suspected uncooperative behavior.
- •22. Subject has a clinically significant hepatic disease or dysfunction or renal
- •dysfunction (creatinine >2.0 mg/dl).
- •23. Subject has an increased risk of hemorrhage.
- •24. Subject has a diabetic nephropathy with albuminuria (protein >1.5 g).
- •25. Subject is pregnant or breast feeding.
- •26. Subject uses an inadequate method of contraception.
- •27. Subject has to undergo ongoing dialysis.
- •28. Subject has an inadequately controlled angina pectoris.
- •29. Subject has an inadequately controlled cardiac failure (NYHA grade III and IV).
- •30. Subject has an inadequately controlled cardiac arrhythmia.
- •31. Subject has upper grade cardiac valve disorders.
- •32. Subject has a history and/or suspicion of pulmonary edema or pulmonary
- •infiltration.
- •33. Subject has a severe chronic obstructive pulmonary disease.
- 另有 4 项未显示
研究者
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