Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)
This study has been completed.
Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00292435
First received: February 15, 2006
Last updated: October 28, 2013
Last verified: October 2013
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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
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 Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on February 25, 2015