Conditions: Stage II Peripheral Arterial Occlusive Disease Intermittent Claudication Fontaine Stage II PAOD
Keywords: Alprostadil Prostaglandin E1 Prostavasin® PAOD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 561
Healthy volunteers: no

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 walking distance in patients with Intermittent Claudication.

Detailed description:

Arms:
arm 1: Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral arm 2: Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous

Interventions: intervention 1: Alprostadil (Prostaglandin E1) intervention 2: Pentoxifylline intervention 3: Placebo to Pentoxifylline oral intervention 4: Placebo to Alprostadil (Prostaglandin E1) intravenous
Intervention descriptions: intervention 1: 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours.

4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours. intervention 2: 4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets. intervention 3: 4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets.

4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets. intervention 4: 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours.

4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours.

Protocol document: