Prostaglandin E1 in Outpatients With Intermittent Claudication

PHASE3CompletedINTERVENTIONAL
Enrollment

561

Participants

Timeline

Start Date

April 30, 2001

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Stage II Peripheral Arterial Occlusive DiseaseIntermittent Claudication Fontaine Stage II PAOD
Interventions
DRUG

Alprostadil (Prostaglandin E1)

"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."

DRUG

Pentoxifylline

"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."

DRUG

Placebo to Pentoxifylline oral

"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."

DRUG

Placebo to Alprostadil (Prostaglandin E1) intravenous

"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."

Trial Locations (36)

Unknown

Aachen

Bad Säckingen

Berlin

Bottrop

Cologne

Dortmund

Dresden

Düsseldorf

Essen

Essen-Steele

Freiburg im Breisgau

Gaggenau

Görlitz

Hamburg

Hanover

Hattingen

Heidelberg

Homburg

Jena

Karlsbad-Lang Ensteinbach

Kassel

Krefeld

Leipzig

Lüneburg

Mannheim

Mannheim-Lindenhof

Mönchengladbach

München

Neuss

Nuremberg

Osnabrück

Papenburg

Regensburg

Seesen

Warendorf

Wuppertal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY