Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01263925
Previous Study | Return to List | Next Study

Prostaglandin E1 in Outpatients With Intermittent Claudication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01263925
Recruitment Status : Completed
First Posted : December 21, 2010
Results First Posted : June 29, 2012
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Stage II Peripheral Arterial Occlusive Disease
Intermittent Claudication Fontaine Stage II PAOD
Interventions Drug: Alprostadil (Prostaglandin E1)
Drug: Pentoxifylline
Drug: Placebo to Pentoxifylline oral
Drug: Placebo to Alprostadil (Prostaglandin E1) intravenous
Enrollment 561
Recruitment Details Of the 607 screened subjects, 561 have been randomized. Of these 561 randomized subjects, 541 are included in the Full Analysis Set (FAS). FAS includes all randomized subjects who received at least one dose of trial medication and who have at least one valid measurement of pain-free walking distance under therapy.
Pre-assignment Details Participant Flow shows all randomized subjects. Baseline Characteristics refer to the FAS.
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Period Title: Overall Study
Started 276 285
Full Analysis Set 269 272
Completed 225 233
Not Completed 51 52
Reason Not Completed
Protocol Violation             1             0
Lack of Efficacy             0             1
Adverse Event             23             22
Unsatisfactory Compliance of Subject             8             5
Withdrawal by Subject             6             8
Other             4             4
Lost to Follow-up             3             1
Lack of Efficacy/ Adverse Event (AE)             1             1
AE/ Unsatisfactory Compliance             2             2
AE/ Withdrawal             1             4
Unsatisfactory Compliance/ Withdrawal             1             1
Unsatisfactory Compl./ Lost to Follow up             1             2
Withdrawal/ Not specified             0             1
Arm/Group Title Alprostadil Pentoxifylline Total
Hide Arm/Group Description

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Total of all reporting groups
Overall Number of Baseline Participants 269 272 541
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 269 participants 272 participants 541 participants
66.3  (8.6) 66.8  (8.8) 66.5  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 269 participants 272 participants 541 participants
Female
84
  31.2%
89
  32.7%
173
  32.0%
Male
185
  68.8%
183
  67.3%
368
  68.0%
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 269 participants 272 participants 541 participants
Caucasian 269 271 540
Asian 0 1 1
Age categories  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 269 participants 272 participants 541 participants
>18 - <65 108 100 208
>=65 - <75 114 119 233
>=75 47 53 100
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 269 participants 272 participants 541 participants
77.8  (13.9) 77.9  (13.5) 77.9  (13.7)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 269 participants 272 participants 541 participants
170.2  (8.6) 169.3  (8.6) 169.7  (8.6)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram/ meter^2 (kg/m^2)
Number Analyzed 269 participants 272 participants 541 participants
26.77  (3.87) 27.11  (3.75) 26.94  (3.81)
Duration of Primary Disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 269 participants 272 participants 541 participants
4.9  (5.1) 4.3  (4.4) 4.6  (4.8)
1.Primary Outcome
Title Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline
Hide Description The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From Baseline to the end of 4 weeks of Interval Treatment (Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
2.60  (12.22) 1.98  (3.61)
2.Primary Outcome
Title Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline
Hide Description The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From Baseline to the end of 6-months Follow-up (Period 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
2.27  (3.00) 2.36  (2.69)
3.Primary Outcome
Title Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline
Hide Description The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 1 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
1.58  (1.92) 1.58  (2.59)
4.Secondary Outcome
Title Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1
Hide Description The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
1.25  (0.64) 1.24  (0.50)
5.Secondary Outcome
Title Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1
Hide Description The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
1.54  (1.53) 1.57  (1.10)
6.Secondary Outcome
Title Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2
Hide Description The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 2 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
1.26  (0.85) 1.28  (0.74)
7.Secondary Outcome
Title Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline
Hide Description The ratio of maximum walking distance was calculated by the maximum walking distance after Period 1 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
1.39  (0.53) 1.43  (1.34)
8.Secondary Outcome
Title Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline
Hide Description The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From Baseline to the end of 4 weeks of Interval Treatment (Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
1.64  (0.86) 1.76  (1.78)
9.Secondary Outcome
Title Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1
Hide Description The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
1.20  (0.50) 1.21  (0.41)
10.Secondary Outcome
Title Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline
Hide Description The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From Baseline to the end of 6-months Follow-up (Period 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
1.89  (1.40) 1.99  (1.61)
11.Secondary Outcome
Title Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1
Hide Description The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
1.39  (0.87) 1.42  (0.80)
12.Secondary Outcome
Title Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2
Hide Description The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 2 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Time Frame From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: meter/meter
1.18  (0.58) 1.17  (0.50)
13.Secondary Outcome
Title Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
Hide Description

Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor).

Negative changes show a decrease from Baseline.

Time Frame From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain -0.24  (0.44) -0.27  (0.49)
Functional status -0.21  (0.40) -0.18  (0.41)
Anxiety -0.16  (0.51) -0.18  (0.54)
Mood -0.07  (0.34) -0.08  (0.37)
Social life -0.05  (0.34) -0.02  (0.33)
Expectation of treatment -0.00  (0.42) 0.01  (0.42)
State of general health during the last week -0.51  (1.48) -0.36  (1.60)
Quality of life during the last week -0.37  (1.58) -0.38  (1.78)
14.Secondary Outcome
Title Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
Hide Description

Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor).

Negative changes show a decrease from Baseline.

Time Frame From Baseline to the end of 6-months Follow-up (Period 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description:

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Overall Number of Participants Analyzed 269 272
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain -0.28  (0.57) -0.41  (0.58)
Functional status -0.26  (0.58) -0.35  (0.57)
Anxiety -0.20  (0.64) -0.22  (0.66)
Mood -0.06  (0.48) -0.12  (0.53)
Social life -0.09  (0.43) -0.04  (0.45)
Expectation of treatment 0.07  (0.51) 0.11  (0.49)
State of general health during the last week -0.43  (1.83) -0.48  (1.98)
Quality of life during the last week -0.36  (2.09) -0.39  (2.20)
Time Frame Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Event Reporting Description

Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication.

Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.

 
Arm/Group Title Alprostadil Pentoxifylline
Hide Arm/Group Description

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) Placebo tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

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 and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

All-Cause Mortality
Alprostadil Pentoxifylline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Alprostadil Pentoxifylline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/276 (6.88%)      17/285 (5.96%)    
Blood and lymphatic system disorders     
Iron Deficiency Anaemia * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Cardiac disorders     
Coronary Artery Disease * 1  3/276 (1.09%)  3 1/285 (0.35%)  1
Angina Pectoris * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Left Ventricular Failure * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Cardiac Failure * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Ischaemic Cardiomyopathy * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Myocardial Infarction * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Acute Myocardial Infarction * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Arrhythmia * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Atrial Flutter * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Cardiac Failure Acute * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Tachyarrhythmia * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Tachycardia * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Tachycardia Paroxysmal * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Ear and labyrinth disorders     
Vestibular Disorder * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
General disorders     
Oedema Peripheral * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Chest Pain * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Infections and infestations     
Device Related Infection * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Postoperative Wound Infection * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Gangrene * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Tinea Pedis * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Injury, poisoning and procedural complications     
Head Injury * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Investigations     
Cardiac Enzymes Increased * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Cancer * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Bronchial Carcinoma * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Prostatic Adenoma * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Nervous system disorders     
Carotid Artery Stenosis * 1  3/276 (1.09%)  3 0/285 (0.00%)  0
Intercostal Neuralgia * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Psychiatric disorders     
Suicide Attempt * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Renal and urinary disorders     
Renal Failure Chronic * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Reproductive system and breast disorders     
Genital Haemorrhage * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Vascular disorders     
Peripheral Arterial Occlusive Disease * 1  4/276 (1.45%)  4 1/285 (0.35%)  1
Haematoma * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Phlebitis * 1  1/276 (0.36%)  1 0/285 (0.00%)  0
Extremity Necrosis * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
Peripheral Ischaemia * 1  0/276 (0.00%)  0 1/285 (0.35%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Alprostadil Pentoxifylline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/276 (21.74%)      55/285 (19.30%)    
Cardiac disorders     
Angina Pectoris * 1  0/276 (0.00%)  0 4/285 (1.40%)  4
Ear and labyrinth disorders     
Vertigo * 1  2/276 (0.72%)  2 5/285 (1.75%)  5
Gastrointestinal disorders     
Diarrhoea * 1  3/276 (1.09%)  3 4/285 (1.40%)  5
Abdominal Pain Upper * 1  2/276 (0.72%)  2 6/285 (2.11%)  6
Gastritis * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Nausea * 1  0/276 (0.00%)  0 9/285 (3.16%)  10
Vomiting * 1  0/276 (0.00%)  0 3/285 (1.05%)  3
General disorders     
Oedema Peripheral * 1  4/276 (1.45%)  4 2/285 (0.70%)  2
Influenza Like Illness * 1  3/276 (1.09%)  3 5/285 (1.75%)  6
Infusion Site Irritation * 1  3/276 (1.09%)  3 0/285 (0.00%)  0
Infusion Site Swelling * 1  3/276 (1.09%)  4 0/285 (0.00%)  0
Infusion Site Erythema * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Infusion Site Extravasation * 1  0/276 (0.00%)  0 2/285 (0.70%)  4
Infusion Site Haematoma * 1  0/276 (0.00%)  0 2/285 (0.70%)  2
Infections and infestations     
Gastroenteritis * 1  3/276 (1.09%)  3 2/285 (0.70%)  2
Nasopharyngitis * 1  2/276 (0.72%)  2 3/285 (1.05%)  3
Tooth Infection * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Urinary Tract Infection * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Bronchitis * 1  0/276 (0.00%)  0 2/285 (0.70%)  2
Injury, poisoning and procedural complications     
Fall * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Investigations     
Blood Creatinine Increased * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Blood Glucose Increased * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Transaminases Increased * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Blood Pressure Increased * 1  0/276 (0.00%)  0 2/285 (0.70%)  2
Blood Triglycerides Increased * 1  0/276 (0.00%)  0 3/285 (1.05%)  3
Metabolism and nutrition disorders     
Diabetes Mellitus * 1  3/276 (1.09%)  3 0/285 (0.00%)  0
Hyperlipidaemia * 1  3/276 (1.09%)  3 4/285 (1.40%)  4
Hypertriglyceridaemia * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain * 1  4/276 (1.45%)  4 2/285 (0.70%)  2
Pain in Extremity * 1  3/276 (1.09%)  3 0/285 (0.00%)  0
Arthralgia * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Muscle Spasms * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Musculoskeletal Discomfort * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Nervous system disorders     
Dizziness * 1  3/276 (1.09%)  3 0/285 (0.00%)  0
Headache * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Psychiatric disorders     
Sleep Disorder * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Insomnia * 1  0/276 (0.00%)  0 2/285 (0.70%)  2
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  2/276 (0.72%)  3 2/285 (0.70%)  2
Skin and subcutaneous tissue disorders     
Night Sweats * 1  0/276 (0.00%)  0 2/285 (0.70%)  2
Vascular disorders     
Hypertension * 1  4/276 (1.45%)  4 4/285 (1.40%)  4
Flushing * 1  3/276 (1.09%)  3 0/285 (0.00%)  0
Phlebitis * 1  2/276 (0.72%)  2 0/285 (0.00%)  0
Thrombophlebitis * 1  0/276 (0.00%)  0 2/285 (0.70%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01263925    
Other Study ID Numbers: SP0580
First Submitted: December 17, 2010
First Posted: December 21, 2010
Results First Submitted: April 17, 2012
Results First Posted: June 29, 2012
Last Update Posted: October 27, 2014