Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT00292435
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2006-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014689', 'term': 'Venous Insufficiency'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C499994', 'term': 'AS 195'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2006-02-15', 'studyFirstSubmitQcDate': '2006-02-15', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.', 'timeFrame': '84 days'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in limb volume on days 21 and 42 determined by water displacement.', 'timeFrame': '21 and 42 days'}, {'measure': 'Change from baseline in calf circumference on days 21, 42, and 84', 'timeFrame': '21, 42 and 84 days'}, {'measure': 'Change from baseline in the subjective symptoms of CVI (tired heavy legs, sensation of tension in the legs, tingling sensations in the legs, pain in the legs) measured by visual analogue scales (VAS) on days 21, 42, and 84', 'timeFrame': '21, 42 and 84 days'}, {'measure': 'Global assessment of efficacy by the patient on day 84', 'timeFrame': '84 days'}, {'measure': 'Global assessment of efficacy by the investigator on day 84', 'timeFrame': '84 days'}, {'measure': 'Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84', 'timeFrame': '84 days'}, {'measure': 'Incidence of adverse events', 'timeFrame': '84 days'}, {'measure': 'Measurement of vital signs (pulse rate, blood pressure)', 'timeFrame': '84 days'}, {'measure': 'Global assessment of tolerability by the patient and by the investigator on day 84.', 'timeFrame': 'day 84'}]}, 'conditionsModule': {'conditions': ['Venous Insufficiency']}, 'descriptionModule': {'briefSummary': 'To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT']}, 'identificationModule': {'nctId': 'NCT00292435', 'briefTitle': 'Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate Efficacy and Tolerability of Antistax Film-coated Tablets, 360 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency.', 'orgStudyIdInfo': {'id': '1138.10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Read vine leaf extract (AS 195)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'LKH Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'VENEX Venenexperten', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Moravský Beroun', 'country': 'Czechia', 'facility': 'Neurology-geriatric Institute', 'geoPoint': {'lat': 49.79374, 'lon': 17.44212}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Klinik und Poliklinik der Universitat Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Greifswald', 'country': 'Germany', 'facility': 'Klinik und Poliklinik fur Hautkrankheiten', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Klinikum der Johannes Gutenberg-Universitat', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Minden', 'country': 'Germany', 'facility': 'Gesundheitszentrum Minden', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'city': 'München', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Oberkirch', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.53241, 'lon': 8.07864}}, {'city': 'Rottweil', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.16783, 'lon': 8.62719}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitats-Hautklinik', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim Study Coordinator', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}}}}