Status:
COMPLETED
Prostaglandin E1 in Outpatients With Intermittent Claudication
Lead Sponsor:
UCB Pharma
Conditions:
Stage II Peripheral Arterial Occlusive Disease
Intermittent Claudication Fontaine Stage II PAOD
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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 walkin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
561 Patients enrolled
Trial Details
Trial ID
NCT01263925
Start Date
April 1 2001
End Date
April 1 2011
Last Update
October 27 2014
Active Locations (36)
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1
Aachen, Germany
2
Bad Säckingen, Germany
3
Berlin, Germany
4
Bottrop, Germany