Effect of NCX4016 on Walking Distance in Patients With Peripheral Arterial Occlusive Disease (PAOD)
This study has been completed.
Sponsor:
NicOx Research Institute S.r.l.
Information provided by:
NicOx Research Institute S.r.l.
ClinicalTrials.gov Identifier:
NCT01256775
First received: December 6, 2010
Last updated: January 18, 2011
Last verified: January 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Intermittent Claudication |
Drug: NCX-4016 Drug: NCX4016 placebo |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by NicOx Research Institute S.r.l.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 442 |
| Study Start Date: | September 2003 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | NicOx Research Institute, Paolo Gresele, University of Perugia - Italy |
| ClinicalTrials.gov Identifier: | NCT01256775 History of Changes |
| Other Study ID Numbers: | NCX4016-X-208 |
| Study First Received: | December 6, 2010 |
| Last Updated: | January 18, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by NicOx Research Institute S.r.l.:
|
atherosclerosis carotid intima-media thickness intermittent claudication Nitric Oxide / NO |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Intermittent Claudication Peripheral Arterial Disease Vascular Diseases Cardiovascular Diseases Arteriosclerosis Signs and Symptoms Atherosclerosis Peripheral Vascular Diseases Nitroaspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cysteine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013