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

Phase 3

Completed

• Conditions: Venous Insufficiency

• Registration Number: NCT00292435
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-16
• Study Start: 2006-03
• Primary Completion: 2006-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 202

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.	84 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84	84 days
Change from baseline in calf circumference on days 21, 42, and 84	21, 42 and 84 days
Global assessment of efficacy by the patient on day 84	84 days
Global assessment of efficacy by the investigator on day 84	84 days
Incidence of adverse events	84 days
Global assessment of tolerability by the patient and by the investigator on day 84.	day 84
Change from baseline in limb volume on days 21 and 42 determined by water displacement.	21 and 42 days
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
Measurement of vital signs (pulse rate, blood pressure)	84 days

Trial Locations

Locations (10)

LKH Graz; 🇦🇹 Graz, Austria

AKH Wien; 🇦🇹 Wien, Austria

VENEX Venenexperten; 🇦🇹 Wien, Austria

Boehringer Ingelheim Investigational Site; 🇩🇪 Rottweil, Germany

Neurology-geriatric Institute; 🇨🇿 Moravsky Beroun, Czech Republic

Klinik und Poliklinik der Universitat Bonn; 🇩🇪 Bonn, Germany

Klinik und Poliklinik fur Hautkrankheiten; 🇩🇪 Greifswald, Germany

Klinikum der Johannes Gutenberg-Universitat; 🇩🇪 Mainz, Germany

Gesundheitszentrum Minden; 🇩🇪 Minden, Germany

Universitats-Hautklinik; 🇩🇪 Tubingen, Germany