Efficacy and Safety CVI, Study 2, (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00292435
First received: February 15, 2006
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Venous Insufficiency
Drug: Read vine leaf extract (AS 195)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment: 200
Estimated Study Completion Date: April 2007
  Eligibility

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292435

Locations
Austria
LKH Graz
Graz, Austria
AKH Wien
Wien, Austria
VENEX Venenexperten
Wien, Austria
Czech Republic
Boehringer Ingelheim Investigational Site
Brno, Czech Republic
Neurology-geriatric Institute
Moravsky Beroun, Czech Republic
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, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00292435     History of Changes
Other Study ID Numbers: 1138.10
Study First Received: February 15, 2006
Last Updated: May 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013