EUCTR2016-004460-19-DE进行中（未招募）1 期
A multi-centre, randomized, placebo-controlled, double-blind trial to assess the efficacy and safety of nitroglycerin sublingual powder on walking distance in a scheduled forced titration design in patients with peripheral arterial occlusive disease (PAOD) and intermittent claudication.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
入选标准
- •1) Male or female outpatients, aged = 18 years
- •2) Ability to exercise a treadmill test
- •3) Confirmation of clinical diagnosis of PAOD as objective evidence of Fontaine stage IIb PAOD i.e.:
- •a) reduced ankle systolic blood pressure (ABI <0.9) on target leg,
- •b) walking distance < 200 m in standardized walking test (initial claudication distance (ICD))
- •4) Completion of at least two treadmill tests within a time interval of = 1 week, the maximum change in claudication distance should not exceed a predefined threshold of 25% for the absolute claudication distance (ACD).
- •5) Intermittent claudication lasting for at least 3 months
- •6) Stable smoking habits for at least 3-6 months prior to inclusion
- •7) Signed Informed Consent
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Asymptomatic PAOD Patients, equivalent to PAOD Fontaine stage I
- •2. PAOD-patients with critical limb ischemia (CLI), equivalent to EMA´s or Fontaine´s PAOD-stages III and IV
- •3. Any kind of revascularization (endovascular, surgical) in the iliac and/or leg arteries within 3 months prior to Visit 1
- •4. Current unstable angina
- •5. History of congestive heart failure, NYHA class III or IV
- •6. Use of confounding medications within the last 4 weeks prior to Visit 1 – e.g. vasoactive compounds like Cilostazol or Naftidrofuryl
- •7. Patients with significant disease of the cardiac valves or symptomatic untreated arrhythmias
- •8. Other diseases limiting exercise capacity (angina pectoris, heart failure, respiratory diseases, orthopedic diseases, neurological disorders)
- •9. Uncontrolled hypertension (> 180/100mmHg) or hypotension (supine SBP <100 mmHg). Whether 24-hour or ambulatory blood pressure monitoring is applied will be at the discretion of the investigator.
- •10. Severe anaemia
- •11. Anamnestically known type I or II diabetes mellitus
- •12. Anamnestically known increased intracranial pressure
- •13. Anamnestically known glaucoma
- •14. Subjects with any clinically relevant laboratory abnormality (assessed by the investigator)
- •The following limits for relevant laboratory abnormality are set in particular:
- •o calculated glomerular filtration rate (GFR) < 30 mL/min/1.73 m2
- •o haemoglobin < 10 g/dl
- •o serum liver enzymes (ASAT, ALAT, GGT) > 3x upper range of normality
- •15. Know hypersensitivity to any ingredient in the product formulation
- •16. Pregnancy or lactation period
- •17. Women of childbearing potential without an effective contraceptive method
- •18. Planned surgical intervention requiring hospitalization during the clinical trial
- •19. Previous inclusion in the present clinical trial or parallel participation in another clinical trial (up to 8 weeks before Visit 1)
- •20. Incapability of understanding nature, meaning and consequences of the clinical trial
- •21. Patient unable to read and / or write
- •22. Patients in custody by juridical or official order
- •23. Patients, who are members of the staff of the trial center, staff of the sponsor or involved
- •24. Clinical Research Organizations (CROs), the investigator him- / herself or close relatives of the investigator
研究者
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