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To assess the efficacy and tolerability of Antistax film coated tablets in patients with chronic venous insufficiency (CVI, CEAP Classification: Clinical class 3 and 4a).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antistax film-coated tablets 360 mg | Active Comparator | Patient to receive 2 tablets daily as a morning dose, each containing 360 mg Antistax |
|
| Placebo | Placebo Comparator | Patient to receive 2 tablets identical to those containing 360 mg Antistax daily as a morning dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red vine leaf extract (AS 195) | Drug | Antistax film-coated tablet 360 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in limb volume determination at day 84 (water displacement method) | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in limb volume determination at day 21 and 42 (water displacement method) | 21 and 42 days | |
| Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs) pain in the legs) measured by Visual Analogue Scales at day 21,42 and 84 |
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Inclusion Criteria:
Exclusion Criteria:
Previous Treatments:
Concomitant Treatment:
Other exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1138.11.49004 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||||
| 1138.11.49016 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21239190 | Derived | Rabe E, Stucker M, Esperester A, Schafer E, Ottillinger B. Efficacy and tolerability of a red-vine-leaf extract in patients suffering from chronic venous insufficiency--results of a double-blind placebo-controlled study. Eur J Vasc Endovasc Surg. 2011 Apr;41(4):540-7. doi: 10.1016/j.ejvs.2010.12.003. Epub 2011 Jan 15. |
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| Placebo | Drug | Placebo tablets identical to those containing Anstistax 360 mg |
|
| 21, 42 and 84 days |
| Incidence of adverse events | 84 days |
| Global assessment of efficacy by the patient at day 84 | 84 days |
| Change from baseline in the calf circumference at day 21, 42 and 84 | 21, 42 and 84 days |
| Global assessment of efficacy by the investigator at day 84 | 84 days |
| Time to improvement in symptoms | 84 days |
| Vital signs (pulse rate, blood pressure) | 84 days |
| Number of patients with abnormal Serum Laboratory Parameters | 84 days |
| Global assessment of tolerability by the patient at day 84 | 84 days |
| Global assessment of tolerability by the investigator at day 84 | 84 days |
| Berlin |
| Germany |
| 1138.11.49019 Boehringer Ingelheim Investigational Site | Bochum | Germany |
| 1138.11.49014 Boehringer Ingelheim Investigational Site | Bonn | Germany |
| 1138.11.49023 Boehringer Ingelheim Investigational Site | Breisach | Germany |
| 1138.11.49003 Boehringer Ingelheim Investigational Site | Coburg | Germany |
| 1138.11.49013 Boehringer Ingelheim Investigational Site | Cologne | Germany |
| 1138.11.49024 Boehringer Ingelheim Investigational Site | Dülmen | Germany |
| 1138.11.49007 Boehringer Ingelheim Investigational Site | Freiburg im Breisgau | Germany |
| 1138.11.49020 Boehringer Ingelheim Investigational Site | Freiburg im Breisgau | 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 |
| 1138.11.49012 Boehringer Ingelheim Investigational Site | Minden | Germany |
| 1138.11.49005 Boehringer Ingelheim Investigational Site | München | Germany |
| 1138.11.49022 Boehringer Ingelheim Investigational Site | Oberhausen | Germany |
| 1138.11.49002 Boehringer Ingelheim Investigational Site | Oberkirch | Germany |
| 1138.11.49001 Boehringer Ingelheim Investigational Site | Rottach-Egern | Germany |
| 1138.11.49006 Boehringer Ingelheim Investigational Site | Rottweil | Germany |
| 1138.11.49018 Boehringer Ingelheim Investigational Site | Tübingen | Germany |
| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C499994 | AS 195 |
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