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

October 28, 2013 updated by: Boehringer Ingelheim

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.

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

Study Overview

Status

Completed

Study Type

Interventional

Enrollment

202

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Graz, Austria
        • LKH Graz
      • Wien, Austria
        • Akh Wien
      • Wien, Austria
        • VENEX Venenexperten
      • Brno, Czech Republic
        • Boehringer Ingelheim Investigational Site
      • Moravsky Beroun, Czech Republic
        • Neurology-geriatric Institute
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • Klinik und Poliklinik der Universitat Bonn
      • Freiburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Greifswald, Germany
        • Klinik und Poliklinik für Hautkrankheiten
      • Koln, Germany
        • Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • Klinikum der Johannes Gutenberg-Universitat
      • Minden, Germany
        • Gesundheitszentrum Minden
      • Munchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Oberkirch, Germany
        • Boehringer Ingelheim Investigational Site
      • Rottweil, Germany
        • Boehringer Ingelheim Investigational Site
      • Tubingen, Germany
        • Universitäts-Hautklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.
Time Frame: 84 days
84 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 1138.10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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