Status:
COMPLETED
Effect of NCX4016 on Walking Distance in Patients With Peripheral Arterial Occlusive Disease (PAOD)
Lead Sponsor:
NicOx Research Institute S.r.l.
Conditions:
Intermittent Claudication
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
Peripheral arterial disease (PAD) is almost invariably associated with a generalized atherosclerotic involvement of the arterial tree and endothelial dysfunction. Previous short term studies showed im...
Detailed Description
Design of the study This was a prospective, randomized, double-blind, parallel-groups, placebo-controlled study conducted in fortythree clinical sites throughout Europe. 442 patients with peripheral a...
Eligibility Criteria
Inclusion
- male and female patients between 40 and 80 years with Leriche-Fontaine stage II PAD presenting symptoms of intermittent claudication stable for at least 6 months
- ankle/brachial index \<0.9
- an absolute claudication distance (ACD) \<500 m
- an initial claudication distance (ICD) \>50 m on a standardized treadmill test (3% incline, 3 km/hr)
- and clinical stability before inclusion (i.e. changes in ACD not exceeding 25% in two standardized treadmill tests during run-in).
- all patients gave their written informed consent.
Exclusion
- unstable symptoms and/or rapid deterioration of PAD during the previous 3 months
- presence of clinically significant renal or hepatic failure, or insulin-dependent type 1 diabetes
- uncontrolled type 2 diabetes, arterial hypertension or dyslipidemia
- any clinical condition limiting the patient's exercise ability (angina pectoris, congestive heart failure, respiratory disease, bone and joint disease, neurological disorders)
- active peptic ulcer during the previous 6 months
- any hemorrhagic condition or history of bleeding
- acute coronary syndrome or acute cerebrovascular episodes during the previous 6 months
- previous revascularization procedures during the last 6 months or indication for vascular surgery; ischemic rest pain
- life expectancy \<12 months
- pregnancy or lactation
- participation to other investigational trials within 3 months prior to inclusion
- history of hypersensitivity or any form of allergic reaction or contraindications to NSAIDs, aspirin, and NO-donating drugs
- the following treatments were not allowed for the period of the study: continuative use (\>7 days) of NSAIDs or nitrovasodilating drugs
- phosphodiesterase type 5 inhibitors, anticoagulants, heparin, ticlopidine, clopidogrel, indobufen, defibrotide, mesoglycan, picotamide, pentoxyfylline, carnitine, sulodexide
- All other concomitant treatments were kept constant as much as possible during the study period.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT01256775
Start Date
September 1 2003
End Date
April 1 2005
Last Update
January 19 2011
Active Locations (1)
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1
Ospedale di Perugia
Perugia, Italy, Italy, 06126