Phase 3 N=561 Randomized Double-blind Treatment

Prostaglandin E1 in Outpatients With Intermittent Claudication

Stage II Peripheral Arterial Occlusive Disease · Intermittent Claudication Fontaine Stage II PAOD

Bottom Line

View on ClinicalTrials.gov: NCT01263925 ↗

Enrolled (actual)

561

Serious AEs

6.4%

Results posted

Jun 2012

Primary outcome: Primary: Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline — 2.60; 1.98 meter/meter

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Alprostadil (Prostaglandin E1) (Drug); Pentoxifylline (Drug); Placebo to Pentoxifylline oral (Drug); Placebo to Alprostadil (Prostaglandin E1) intravenous (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: UCB Pharma
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline	2.60; 1.98	—
PRIMARY Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline	2.27; 2.36	—
PRIMARY Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline	1.58; 1.58	—
SECONDARY Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1	1.25; 1.24	—
SECONDARY Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1	1.54; 1.57	—
SECONDARY Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2	1.26; 1.28	—
SECONDARY Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline	1.39; 1.43	—
SECONDARY Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline	1.64; 1.76	—
SECONDARY Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1	1.20; 1.21	—
SECONDARY Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline	1.89; 1.99	—
SECONDARY Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1	1.39; 1.42	—
SECONDARY Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2	1.18; 1.17	—
SECONDARY Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1	-0.24; -0.27; -0.21; -0.18; -0.16; -0.18	—
SECONDARY Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3	-0.28; -0.41; -0.26; -0.35; -0.20; -0.22	—

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.

Eligibility Criteria

Inclusion Criteria

Subjects with Peripheral Arterial Occlusive Disease (PAOD) of the lower extremity in Fontaine stage II
Maximum walking distance on the treadmill (12 %, 3 km/h) between 30 and 150 m
Stable Intermittent Claudication of at least 6 months standing with no acute shortening of walking distance over the past 3 months
Stenoses or occlusions below the Femoral Bifurcation (above-knee or below-knee type) confirmed by duplex US or angiography
Ankle/brachial index ≤ 0.90 with a decrease in systolic ankle pressure of ≥ 10 % after maximum loading (maximum walking distance on the treadmill at 3 km/h, 12 %)
The patient is physically and mentally capable of participating in the trial
Patient age > 40 years, male and female
Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
Patient is willing and able to comply with all trial requirements

Exclusion Criteria

Surgical or other interventional measures performed on the affected extremity and Prostaglandin treatment within the 6 months immediately prior to the trial
Rest pain and Necroses
Systolic ankle pressure less than 50 mmHg
Change in maximum walking distance during the one-week Run-in Phase of more than ± 25 % of Baseline
Successful physical walking training within the 6 months immediately prior to the trial
Inflammatory vascular diseases
Polyneuropathy in Diabetes Mellitus
Diseases limiting walking distance (Arthrosis, inflammatory diseases of the joints, neurological disease, diseases of the Vertebral Column, cardiopulmonary diseases)
History of Pulmonary Oedema
Myocardial infarction within the past 6 months
Pregnancy or nursing
Known hypersensitivity to any components of the trial medication or comparative drug
Renal insufficiency, compensated retention (creatinine > 2.0 mg/dL)
Severe retinal Haemorrhage
Massive Haemorrhage
Known existing malignant diseases
Vasoactive concomitant medication (e.g. Naftidrofuryl, Pentoxifylline, Buflomedil, Cilostazol), or other Prostaglandins
Untreated or uncontrolled Hypertension (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg)
Previous participation of the patient in the present trial
Participation of the patient in a trial with the same objectives within the past 6 months, or is currently participating in another trial
Illness of the patient due to alcohol or drug-abuse within the past 6 months
Serious illness of the patient that the investigator considers to compromise his/her participation in the trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01263925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.