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Effect of NCX4016 on Walking Distance in Patients With Peripheral Arterial Occlusive Disease (PAOD)

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. Identifier: NCT01256775
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : January 19, 2011
Information provided by:
NicOx Research Institute S.r.l.

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 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.

Condition or disease Intervention/treatment Phase
Intermittent Claudication Drug: NCX-4016 Drug: NCX4016 placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Arm Intervention/treatment
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.
Drug: NCX-4016
NCX4016 800 mg b.i.d. for 6 months on top of aspirin 100 mg o.d.

Primary Outcome Measures :
  1. maximal walking distance evaluated by a constant treadmill test [ Time Frame: baseline ]
  2. maximal walking distance evaluated by a constant treadmill test [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. pain-free walking distance [ Time Frame: baseline, 1-3-6 months ]
  2. assessment of carotid artery IMT [ Time Frame: baseline and 6 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01256775

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Ospedale di Perugia
Perugia, Italy, 06126
Sponsors and Collaborators
NicOx Research Institute S.r.l.
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Principal Investigator: Paolo Gresele, M.D., Ph.D. University of Perugia, Italy
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Responsible Party: NicOx Research Institute, Paolo Gresele, University of Perugia - Italy Identifier: NCT01256775    
Other Study ID Numbers: NCX4016-X-208
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011
Keywords provided by NicOx Research Institute S.r.l.:
carotid intima-media thickness
intermittent claudication
Nitric Oxide / NO
Additional relevant MeSH terms:
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Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cyclooxygenase Inhibitors