CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 561 enrolled
Drug / intervention
Alprostadil (Prostaglandin E1) +3 moredrug
Likely dose
Alprostadil (Prostaglandin E1) 20 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01263925
NCT01263925Phase 3Completed
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Intravenous Prostaglandin E1 Treatment in Outpatients With Intermittent Claudication

UCB Pharma·interventional·Posted Dec 21, 2010·Updated Oct 27, 2014

In Brief

A Phase 3 clinical trial evaluating Alprostadil (Prostaglandin E1), Pentoxifylline, and 2 other interventions for Stage II Peripheral Arterial Occlusive Disease and Intermittent Claudication Fontaine Stage II PAOD. Completed, enrolled 561 participants across 36 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage II Peripheral Arterial Occlusive Disease, Intermittent Claudication Fontaine Stage II PAOD
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 21, 2010
Enrollment StartApr 1, 2001
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 15.5 years ago

Interventions

Alprostadil (Prostaglandin E1)drug

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.

Pentoxifyllinedrug

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.

Placebo to Pentoxifylline oraldrug

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.

Placebo to Alprostadil (Prostaglandin E1) intravenousdrug

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.