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NCT00292435 Clinical Trial

Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)

Venous Insufficiency Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00292435
Other study ID # 1138.10
Secondary ID
Status Completed
Phase Phase 3
First received February 15, 2006
Last updated October 28, 2013
Start date March 2006

Study information
Verified date October 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

— Not specified —

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Read vine leaf extract (AS 195)

Locations
Country Name City State
Austria LKH Graz Graz
Austria AKH Wien Wien
Austria VENEX Venenexperten Wien
Czech Republic Boehringer Ingelheim Investigational Site Brno
Czech Republic Neurology-geriatric Institute Moravsky Beroun
Germany Boehringer Ingelheim Investigational Site Berlin
Germany Klinik und Poliklinik der Universitat Bonn Bonn
Germany Boehringer Ingelheim Investigational Site Freiburg
Germany Klinik und Poliklinik fur Hautkrankheiten Greifswald
Germany Boehringer Ingelheim Investigational Site Koln
Germany Klinikum der Johannes Gutenberg-Universitat Mainz
Germany Gesundheitszentrum Minden Minden
Germany Boehringer Ingelheim Investigational Site Munchen
Germany Boehringer Ingelheim Investigational Site Oberkirch
Germany Boehringer Ingelheim Investigational Site Rottweil
Germany Universitats-Hautklinik Tubingen

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement. 84 days No
Secondary Change from baseline in limb volume on days 21 and 42 determined by water displacement. 21 and 42 days No
Secondary Change from baseline in calf circumference on days 21, 42, and 84 21, 42 and 84 days No
Secondary 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 21, 42 and 84 days No
Secondary Global assessment of efficacy by the patient on day 84 84 days No
Secondary Global assessment of efficacy by the investigator on day 84 84 days No
Secondary Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84 84 days No
Secondary Incidence of adverse events 84 days No
Secondary Measurement of vital signs (pulse rate, blood pressure) 84 days No
Secondary Global assessment of tolerability by the patient and by the investigator on day 84. day 84 No
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