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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00292435
First received: February 15, 2006
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to 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:

Primary Outcome Measures:
  • Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement. [ Time Frame: 84 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in limb volume on days 21 and 42 determined by water displacement. [ Time Frame: 21 and 42 days ] [ Designated as safety issue: No ]
  • Change from baseline in calf circumference on days 21, 42, and 84 [ Time Frame: 21, 42 and 84 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Global assessment of efficacy by the patient on day 84 [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Global assessment of efficacy by the investigator on day 84 [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84 [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Measurement of vital signs (pulse rate, blood pressure) [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Global assessment of tolerability by the patient and by the investigator on day 84. [ Time Frame: day 84 ] [ Designated as safety issue: No ]

Estimated Enrollment: 202
Study Start Date: March 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

  Contacts and Locations
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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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  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: October 28, 2013
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 July 26, 2014