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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00855179 |
To assess the efficacy and tolerability of Antistax film coated tablets in patientswith chronic venous insufficiency (CVI, CEAP Classification: Clinical class 3 and 4a).
Condition | Intervention | Phase |
---|---|---|
Venous Insufficiency |
Drug: Red vine leaf extract (AS 195) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Efficacy Study |
Official Title: | A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate Efficacy and Tolerability of Antistax® Film Coated Tablets, 720 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency |
Estimated Enrollment: | 240 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Previous Treatments:
Concomitant Treatment:
Other exclusion Criteria:
Germany | |
1138.11.49002 Boehringer Ingelheim Investigational Site | |
Oberkirch, Germany | |
1138.11.49003 Boehringer Ingelheim Investigational Site | |
Coburg, Germany | |
1138.11.49004 Boehringer Ingelheim Investigational Site | |
Berlin, Germany | |
1138.11.49001 Boehringer Ingelheim Investigational Site | |
Rottach-Egern, Germany | |
1138.11.49005 Boehringer Ingelheim Investigational Site | |
München, Germany | |
1138.11.49006 Boehringer Ingelheim Investigational Site | |
Rottweil, Germany | |
1138.11.49007 Boehringer Ingelheim Investigational Site | |
Freiburg, Germany | |
1138.11.49009 Boehringer Ingelheim Investigational Site | |
Greifswald, Germany | |
1138.11.49010 Boehringer Ingelheim Investigational Site | |
Lübeck, Germany | |
1138.11.49011 Boehringer Ingelheim Investigational Site | |
Mainz, Germany | |
1138.11.49023 Boehringer Ingelheim Investigational Site | |
Breisach, Germany | |
1138.11.49013 Boehringer Ingelheim Investigational Site | |
Köln, Germany | |
1138.11.49014 Boehringer Ingelheim Investigational Site | |
Bonn, Germany | |
1138.11.49016 Boehringer Ingelheim Investigational Site | |
Berlin, Germany | |
1138.11.49019 Boehringer Ingelheim Investigational Site | |
Bochum, Germany | |
1138.11.49020 Boehringer Ingelheim Investigational Site | |
Freiburg, Germany | |
1138.11.49022 Boehringer Ingelheim Investigational Site | |
Oberhausen, Germany | |
1138.11.49018 Boehringer Ingelheim Investigational Site | |
Tübingen, Germany | |
1138.11.49024 Boehringer Ingelheim Investigational Site | |
Dülmen, Germany | |
1138.11.49017 Boehringer Ingelheim Investigational Site | |
Bonn, Germany | |
1138.11.49012 Boehringer Ingelheim Investigational Site | |
Minden, Germany |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1138.11 |
Study First Received: | March 3, 2009 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00855179 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Embolism and Thrombosis Embolism Venous Insufficiency Vascular Diseases |
Venous Thrombosis Postthrombotic Syndrome Thrombosis Postphlebitic Syndrome |
Embolism and Thrombosis Venous Insufficiency Vascular Diseases Venous Thrombosis |
Cardiovascular Diseases Postthrombotic Syndrome Thrombosis |