Trials / Completed
CompletedNCT01263925
Prostaglandin E1 in Outpatients With Intermittent Claudication
Intravenous Prostaglandin E1 Treatment in Outpatients With Intermittent Claudication
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 561 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2001-04-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2010-12-21
- Last updated
- 2014-10-27
- Results posted
- 2012-06-29
Locations
36 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01263925. Inclusion in this directory is not an endorsement.