Clinical trial NCT00292435: Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Insufficiency
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-02-16
Enrollment: 202
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms



Primary outcomes:
measure: Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.
timeFrame: 84 days
Secondary outcomes:
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
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Graz
city: Wien
country: Austria
facility: AKH Wien
city: Wien
country: Austria
facility: VENEX Venenexperten
city: Brno
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Moravsky Beroun
country: Czech Republic
facility: Neurology-geriatric Institute
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: Klinik und Poliklinik der Universitat Bonn
city: Freiburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Greifswald
country: Germany
facility: Klinik und Poliklinik fur Hautkrankheiten
city: Koln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg-Universitat
city: Minden
country: Germany
facility: Gesundheitszentrum Minden
city: Munchen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Oberkirch
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rottweil
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Tubingen
country: Germany
facility: Universitats-Hautklinik
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: