Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 12:01 PM
Study NCT ID:
NCT00102050
Status:
COMPLETED
Last Update Posted:
2006-05-19
First Post:
2005-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C516117', 'term': '4-bromo-6-(3-(4-chlorophenyl)propoxy)-5-(3-pyridylmethylamino)-3(2H)-pyridazinone hydrochloride'}, {'id': 'D010726', 'term': 'Phosphodiesterase Inhibitors'}], 'ancestors': [{'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'statusVerifiedDate': '2006-05', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2006-05-17', 'studyFirstSubmitDate': '2005-01-19', 'studyFirstSubmitQcDate': '2005-01-19', 'lastUpdatePostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in peak walking time at 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Improvement in claudication onset time at 24 weeks'}, {'measure': 'Health status survey questionnaire'}, {'measure': 'Walking impairment questionnaire'}]}, 'conditionsModule': {'keywords': ['NM-702 tablets', 'intermittent claudication', 'peripheral', 'arterial', 'vascular', 'peripheral arterial disease'], 'conditions': ['Intermittent Claudication', 'Peripheral Vascular Disease']}, 'descriptionModule': {'briefSummary': 'NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 taken twice a day (BID) for 24 weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of Intermittent Claudication.', 'detailedDescription': 'NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 BID for 24 weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of Intermittent Claudication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities\n* Median treadmill peak walking time between 90 and 600 seconds\n\nExclusion Criteria:\n\n* Symptoms of limb threatening ischemia (ischemic rest pain, ischemic ulceration and/or gangrene)\n* Clinically significant pulmonary, neurological or skeletal dysfunction (e.g., lumbar canal stenosis, emphysema, uncontrolled angina, multiple sclerosis, or gait altering amputation) that would directly interfere or limit exercise testing\n* Subjects who have had, or will require, a peripheral revascularization procedure within 12 weeks prior to or following treatment initiation.\n* A resting blood pressure greater than 150/100 and other clinically significant results.'}, 'identificationModule': {'nctId': 'NCT00102050', 'briefTitle': 'Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nissan Chemical Industries'}, 'officialTitle': 'A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NM-702 in Subjects With Intermittent Claudication', 'orgStudyIdInfo': {'id': 'NCI-IC-0201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NM-702 (phosphodiesterase inhibitor)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92501', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '66204', 'city': 'Shawnee Mission', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 39.02, 'lon': -94.66583}}, {'zip': '70124', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '43606', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98431', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigator', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nissan Chemical Industries', 'class': 'INDUSTRY'}}}}