Prostaglandin E1 in Outpatients With Intermittent Claudication

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Alprostadil; Pentoxifylline

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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