drugset / Trial / NCT03469349

Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB

NCT03469349 ↗

Phase 3 Completed 366 enrolled Takeda
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy and safety of actovegin in participants with peripheral arterial disease (PAD) Fontaine Stage IIB.

Timeline

Start
2018-05-01
Primary completion
2019-05-28
Completion
2019-08-28

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Actovegin 1200 mg; p = 0.0041; Least square mean difference 29.19 (95% CI 9.35 to 49.02); MMRM NCT03469349 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Actovegin Protein / enzyme biologic 200 mg Intravenous