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COMPLETEDPHASE4

Efficacy and Safety of Coumarin and Troxerutin in the Symptomatic Treatment of Chronic Venous Insufficiency

Evaluation of Efficacy and Safety of the Fixed-dose Combination of Coumarin and Troxerutin (Venalot®) Versus Placebo in the Symptomatic Treatment of Chronic Venous Insufficiency - VENACT

NCT01848210•Takeda

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of the fixed-dose combination of coumarin and troxerutin versus placebo in the symptomatic treatment of chronic venous insufficiency.

Detailed Description

The drug being tested in this study is the fixed-dose combination of coumarin and troxerutin called Venalot®. Venalot is being tested to treat the symptoms of chronic venous insufficiency. This study will look at symptom relief in people who take Venalot®. The study will enroll approximately 808 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Combination coumarin + troxerutin extended release tablets * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient. All participants will be asked to take two tablets three times a day throughout the study. This multi-centre trial will be conducted in Brazil. The overall time to participate in this study is up to 18 weeks. Participants will make 6 visits to the clinic.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Consent of subject or legal representative
•2. Men or women of any ethnicity, aged between 18 and 75 years, and body mass index (BMI) equal or less than 40.
•3. Is able to use properly the medication according to protocol.
•4. Has chronic venous insufficiency in the reference leg with the clinical classification C3, or C4a orC4b or C5, provided that in two last situations the present lipodermatosclerosis does not compromise more than 1/3 portion of the leg immersed or immersible in the plethysmometer.
•5. Has stable edema (in a steady state), equivalent to a variation lower than or equal to 10% in partial volume of the reference leg between the screening visit and the randomization visit, and present for at least 6 months.
•6. Scoring in "Severity Score of Local Complaints" equal to or higher than 5 total points.
•7. Women who are using an effective (at the discretion of the investigator), but not hormonal, birth control method (not hormonal intrauterine device (IUD), surgical sterilization, among others), or who are postmenopausal, in addition to condom use (mandatory).

Exclusion Criteria

•1. Has chronic venous insufficiency classified as C1, C2 in the reference leg or C6 in any leg.
•2. Has chronic venous insufficiency C4b or C5 in the reference leg, with lipodermatosclerosis present in more than 1/3 portion of the leg immersed in the plethysmometer.
•3. Has unstable edema, equivalent to variation of more than 10% of partial volume in the reference leg between the screening visit and randomization visit, prior to start of treatment.
•4. Has venous obstruction and/or deep vein thrombosis (DVT) and/or presence of phlebitis in lower limbs during the last 3 (three) months.
•5. Has developed deep vein insufficiency during the last 3 (three) months.
•6. Has other diseases that may interfere in the findings of the study such as: lymphedema, thrombosis, clotting disorders, edema of lower limbs due to right-sided heart failure, arterial obstruction of lower limbs and other conditions that, at medical discretion, are relevant to exclusion, particularly symptoms which are similar to the symptomatology of chronic venous insufficiency.
•7. Has a history of surgery at the venous system or sclerotherapy or who received any treatment for chronic venous insufficiency during the last 03 months, whether it was by drug, elastic stocking, laser, or surgery.
•8. Has used previously Venalot® and had no benefits with the treatment.
•9. Has a previous history of known or suspected allergy or intolerance to any of the ingredients of the medicinal product under investigation.
•10. Has any clinical finding (history and physical examination) that is interpreted by the physician-investigator as a risk to participant's participation in the study.
+14 more criteria

Key Dates

Start Date

May 1, 2013

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

November 11, 2016

Enrollment

829

ACTUAL participants

Conditions

Chronic Venous Insufficiency

Interventions

Coumarin/troxerutin

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Coumarin and Troxerutin in the Symptomatic Treatment of Chronic Venous Insufficiency

Inclusion Criteria

Exclusion Criteria

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