Intravenous Prostaglandin E1 Treatment in Outpatients With Intermittent Claudication
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 561
- 主要终点
- Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline
研究概览
简要总结
Investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with Prostaglandin E1 and that of 4 weeks of interval treatment (two infusions per week) on the pain-free walking distance in patients with Intermittent Claudication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Peripheral Arterial Occlusive Disease (PAOD) of the lower extremity in Fontaine stage II
- •Maximum walking distance on the treadmill (12 %, 3 km/h) between 30 and 150 m
- •Stable Intermittent Claudication of at least 6 months standing with no acute shortening of walking distance over the past 3 months
- •Stenoses or occlusions below the Femoral Bifurcation (above-knee or below-knee type) confirmed by duplex US or angiography
- •Ankle/brachial index ≤ 0.90 with a decrease in systolic ankle pressure of ≥ 10 % after maximum loading (maximum walking distance on the treadmill at 3 km/h, 12 %)
- •The patient is physically and mentally capable of participating in the trial
- •Patient age > 40 years, male and female
- •Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
- •Patient is willing and able to comply with all trial requirements
排除标准
- •Surgical or other interventional measures performed on the affected extremity and Prostaglandin treatment within the 6 months immediately prior to the trial
- •Rest pain and Necroses
- •Systolic ankle pressure less than 50 mmHg
- •Change in maximum walking distance during the one-week Run-in Phase of more than ± 25 % of Baseline
- •Successful physical walking training within the 6 months immediately prior to the trial
- •Inflammatory vascular diseases
- •Polyneuropathy in Diabetes Mellitus
- •Diseases limiting walking distance (Arthrosis, inflammatory diseases of the joints, neurological disease, diseases of the Vertebral Column, cardiopulmonary diseases)
- •History of Pulmonary Oedema
- •Myocardial infarction within the past 6 months
- •Pregnancy or nursing
- •Known hypersensitivity to any components of the trial medication or comparative drug
- •Renal insufficiency, compensated retention (creatinine > 2.0 mg/dL)
- •Severe retinal Haemorrhage
- •Massive Haemorrhage
- •Known existing malignant diseases
- •Vasoactive concomitant medication (e.g. Naftidrofuryl, Pentoxifylline, Buflomedil, Cilostazol), or other Prostaglandins
- •Untreated or uncontrolled Hypertension (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg)
- •Previous participation of the patient in the present trial
- •Participation of the patient in a trial with the same objectives within the past 6 months, or is currently participating in another trial
- •Illness of the patient due to alcohol or drug-abuse within the past 6 months
- •Serious illness of the patient that the investigator considers to compromise his/her participation in the trial
研究组 & 干预措施
Alprostadil
Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral
干预措施: Alprostadil (Prostaglandin E1) (Drug)
Alprostadil
Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral
干预措施: Placebo to Pentoxifylline oral (Drug)
Pentoxifylline
Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous
干预措施: Pentoxifylline (Drug)
Pentoxifylline
Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous
干预措施: Placebo to Alprostadil (Prostaglandin E1) intravenous (Drug)
结局指标
主要结局
Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline
时间窗: From Baseline to the end of 6-months Follow-up (Period 3)
The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline
时间窗: From Baseline to the end of 4 weeks of Interval Treatment (Period 2)
The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline
时间窗: From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 1 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
次要结局
- Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline(From Baseline to the end of 4 weeks of Daily Treatment (Period 1))
- Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline(From Baseline to the end of 6-months Follow-up (Period 3))
- Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2(From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3))
- Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1(From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2))
- Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline(From Baseline to the end of 4 weeks of Interval Treatment (Period 2))
- Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2(From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3))
- Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1(From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2))
- Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1(From Baseline to the end of 4 weeks of Daily Treatment (Period 1))
- Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3(From Baseline to the end of 6-months Follow-up (Period 3))
- Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1(From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3))
- Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1(From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3))