Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00292435 |
Recruitment Status :
Completed
First Posted : February 16, 2006
Last Update Posted : October 29, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Venous Insufficiency | Drug: Read vine leaf extract (AS 195) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 202 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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. |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | October 2006 |
- Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement. [ Time Frame: 84 days ]
- Change from baseline in limb volume on days 21 and 42 determined by water displacement. [ Time Frame: 21 and 42 days ]
- Change from baseline in calf circumference on days 21, 42, and 84 [ Time Frame: 21, 42 and 84 days ]
- 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 ]
- Global assessment of efficacy by the patient on day 84 [ Time Frame: 84 days ]
- Global assessment of efficacy by the investigator on day 84 [ Time Frame: 84 days ]
- Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84 [ Time Frame: 84 days ]
- Incidence of adverse events [ Time Frame: 84 days ]
- Measurement of vital signs (pulse rate, blood pressure) [ Time Frame: 84 days ]
- Global assessment of tolerability by the patient and by the investigator on day 84. [ Time Frame: day 84 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292435
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 |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT00292435 History of Changes |
Other Study ID Numbers: |
1138.10 |
First Posted: | February 16, 2006 Key Record Dates |
Last Update Posted: | October 29, 2013 |
Last Verified: | October 2013 |
Venous Insufficiency Vascular Diseases Cardiovascular Diseases |