NCT01848210

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 829 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
DRUG	Coumarin/troxerutin	Coumarin + troxerutin fixed-dose combination tablets
DRUG	Placebo	Coumarin + troxerutin placebo-matching tablets

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-05-07
• Last updated: 2016-11-11
• Results posted: 2016-11-11