Effect of NCX4016 on Walking Distance in Patients With Peripheral Arterial Occlusive Disease (PAOD)
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 improvement of vascular reactivity and walking capacity in PAD patients by measures aimed at restoring Nitric Oxide (NO) production. NO is also known to prevent the progression of atherosclerosis. We wished to assess whether the prolonged administration of a NO-donating agent (NCX 4016) improves the functional capacity of PAD patients and affects the progression of atherosclerosis as assessed by carotid intima-media thickness (IMT).
Four hundred forty two patients with stable intermittent claudication were enrolled in a prospective, double blind, placebo-controlled study and randomized to either NCX 4016 800mg bid or its placebo for 6 months. The primary study outcome was the absolute claudication distance (ACD) on a constant treadmill test (10% incline, 3km/hr); main secondary end-point was the change of the mean far-wall right common carotid artery IMT.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Double-blind, Randomized, Parallel Group Study to Assess the Effect of NCX4016 vs Placebo on Walking Distance in Patients With Peripheral Arterial Occlusive Disease at Leriche-Fontaine Stage II|
- maximal walking distance evaluated by a constant treadmill test [ Time Frame: baseline ] [ Designated as safety issue: No ]
- maximal walking distance evaluated by a constant treadmill test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- pain-free walking distance [ Time Frame: baseline, 1-3-6 months ] [ Designated as safety issue: No ]
- assessment of carotid artery IMT [ Time Frame: baseline and 6 month ] [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
|Study Completion Date:||April 2005|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
Placebo Comparator: NCX4016 placebo
NCX4016 placebo b.i.d for 6 months
Drug: NCX4016 placebo
NCX4016 placebo b.i.d. for 6 months
Active Comparator: NCX4016
ncx4016,800 mg b.i.d., on top of aspirin 100 mg o.d.
NCX4016 800 mg b.i.d. for 6 months on top of aspirin 100 mg o.d.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01256775
|Ospedale di Perugia|
|Perugia, Italy, 06126|
|Principal Investigator:||Paolo Gresele, M.D., Ph.D.||University of Perugia, Italy|