drugset / Trial / NCT01848210

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

NCT01848210 ↗

Phase 4 Completed 829 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-05
Primary completion
2015-09
Completion
2015-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Coumarin + Troxerutin vs Placebo; p = 0.531; Mean Difference (Final Values) -4.65 (95% CI -19.81 to 10.51); Regression, Linear NCT01848210 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Coumarin Small molecule 30 mg Oral
Subject Troxerutin Small molecule 180 mg Oral