Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT00068133
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of VLTS-589 in Subjects With 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'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'statusVerifiedDate': '2005-05', 'completionDateStruct': {'date': '2005-06'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2003-09-08', 'studyFirstSubmitQcDate': '2003-09-09', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-09-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Intermittent Claudication', 'Peripheral Vascular Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT) for subjects receiving VLTS-589 compared with subjects receiving placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Men or women between 40 and 80 years of age,\n* Must give informed consent,\n* Current medical history of peripheral arterial disease, which includes the following symptoms: leg pain, leg discomfort or leg weakness\n\nExclusion criteria:\n\n* Ulcers or gangrene,\n* History of cancer (except skin cancer) within the past 5 years,\n* Participation in another clinical trial within 30 days of enrollment in this trial,\n* Unwillingness or inability to comply with all study requirements'}, 'identificationModule': {'nctId': 'NCT00068133', 'briefTitle': 'Trial of VLTS-589 in Subjects With Intermittent Claudication', 'organization': {'class': 'INDUSTRY', 'fullName': 'Valentis'}, 'officialTitle': 'A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease', 'orgStudyIdInfo': {'id': 'VLTS-589-121'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Plasmid based Gene Transfer product-VLTS-589', 'type': 'GENETIC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cardiology Pc', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Heart Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Access Clinical Trials-Cardiovascular Research', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Heart Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Heart Specialists of Sarasota Clinical Research Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'American Cardiovascular Research Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Rush Presbyterian St. Luke's Medical Center", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': "Prairie Heart Institution at St. John's Hospital", 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Care Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'New Orleans Center for Clinical Research', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'facility': 'Androscoggin Cardiology Associates', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health Systems', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institution Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27715', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Clinical Research Institute', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Science Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98166', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Daniel Gottleib, MD', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valentis', 'class': 'INDUSTRY'}}}}