- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00292435
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
Conditions
Intervention / Treatment
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
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Graz, Austria
- LKH Graz
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Wien, Austria
- Akh Wien
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Wien, Austria
- VENEX Venenexperten
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Brno, Czech Republic
- Boehringer Ingelheim Investigational Site
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Moravsky Beroun, Czech Republic
- Neurology-geriatric Institute
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Berlin, Germany
- Boehringer Ingelheim Investigational Site
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Bonn, Germany
- Klinik und Poliklinik der Universitat Bonn
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Freiburg, Germany
- Boehringer Ingelheim Investigational Site
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Greifswald, Germany
- Klinik und Poliklinik für Hautkrankheiten
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Koln, Germany
- Boehringer Ingelheim Investigational Site
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Mainz, Germany
- Klinikum der Johannes Gutenberg-Universitat
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Minden, Germany
- Gesundheitszentrum Minden
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Munchen, Germany
- Boehringer Ingelheim Investigational Site
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Oberkirch, Germany
- Boehringer Ingelheim Investigational Site
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Rottweil, Germany
- Boehringer Ingelheim Investigational Site
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Tubingen, Germany
- Universitäts-Hautklinik
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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
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84 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events
Time Frame: 84 days
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84 days
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Change from baseline in limb volume on days 21 and 42 determined by water displacement.
Time Frame: 21 and 42 days
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21 and 42 days
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Change from baseline in calf circumference on days 21, 42, and 84
Time Frame: 21, 42 and 84 days
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21, 42 and 84 days
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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
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21, 42 and 84 days
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Global assessment of efficacy by the patient on day 84
Time Frame: 84 days
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84 days
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Global assessment of efficacy by the investigator on day 84
Time Frame: 84 days
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84 days
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Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84
Time Frame: 84 days
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84 days
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Measurement of vital signs (pulse rate, blood pressure)
Time Frame: 84 days
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84 days
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Global assessment of tolerability by the patient and by the investigator on day 84.
Time Frame: day 84
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day 84
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
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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