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

NCT ID: NCT00292435

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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

Detailed Description

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Conditions

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Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Read vine leaf extract (AS 195)

Intervention Type DRUG

Eligibility Criteria

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Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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LKH Graz

Graz, , Austria

Site Status

AKH Wien

Vienna, , Austria

Site Status

VENEX Venenexperten

Vienna, , Austria

Site Status

Boehringer Ingelheim Investigational Site

Brno, , Czechia

Site Status

Neurology-geriatric Institute

Moravský Beroun, , Czechia

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Klinik und Poliklinik der Universitat Bonn

Bonn, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

Site Status

Klinik und Poliklinik fur Hautkrankheiten

Greifswald, , Germany

Site Status

Klinikum der Johannes Gutenberg-Universitat

Mainz, , Germany

Site Status

Gesundheitszentrum Minden

Minden, , Germany

Site Status

Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Oberkirch, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Rottweil, , Germany

Site Status

Universitats-Hautklinik

Tübingen, , Germany

Site Status

Countries

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Austria Czechia Germany

Other Identifiers

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1138.10

Identifier Type: -

Identifier Source: org_study_id