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Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)

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ClinicalTrials.gov Identifier: NCT00292435
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : October 29, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:
To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms

Condition or disease Intervention/treatment Phase
Venous Insufficiency Drug: Read vine leaf extract (AS 195) Phase 3

Study Design
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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
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement. [ Time Frame: 84 days ]

Secondary Outcome Measures :
  1. Change from baseline in limb volume on days 21 and 42 determined by water displacement. [ Time Frame: 21 and 42 days ]
  2. Change from baseline in calf circumference on days 21, 42, and 84 [ Time Frame: 21, 42 and 84 days ]
  3. 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 ]
  4. Global assessment of efficacy by the patient on day 84 [ Time Frame: 84 days ]
  5. Global assessment of efficacy by the investigator on day 84 [ Time Frame: 84 days ]
  6. Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84 [ Time Frame: 84 days ]
  7. Incidence of adverse events [ Time Frame: 84 days ]
  8. Measurement of vital signs (pulse rate, blood pressure) [ Time Frame: 84 days ]
  9. Global assessment of tolerability by the patient and by the investigator on day 84. [ Time Frame: day 84 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
More Information
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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
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases