Prostaglandin E1 in Outpatients With Intermittent Claudication

UCB

Status and phase: Completed; Phase 3

Conditions: Intermittent Claudication Fontaine Stage II PAOD; Stage II Peripheral Arterial Occlusive Disease

Treatments: Drug: Pentoxifylline; Drug: Placebo to Alprostadil (Prostaglandin E1) intravenous; Drug: Placebo to Pentoxifylline oral; Drug: Alprostadil (Prostaglandin E1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01263925

SP0580

Details and patient eligibility

About

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.

Enrollment: 561 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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561 participants in 2 patient groups

Alprostadil

Experimental group

Description:

Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral

Treatment:

Drug: Alprostadil (Prostaglandin E1)

Drug: Placebo to Pentoxifylline oral

Pentoxifylline

Active Comparator group

Description:

Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous

Treatment:

Drug: Placebo to Alprostadil (Prostaglandin E1) intravenous

Drug: Pentoxifylline