NCT03469349

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

A Randomized, International, Multicenter, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Subjects With Peripheral Arterial Occlusive Disease Fontaine Stage IIB

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will enroll approximately 366 participants. Participants will be randomly assigned to one of the two treatment groups in 1:1 ratio: 1. Actovegin 2. Placebo (dummy inactive substance) - this is a tablet/intravenous infusion that looks like the study drug but has no active ingredient All participants will be asked to take intravenous infusion for 2 weeks followed by oral tablets for 10 weeks. This multi-center trial will be conducted Russia, Georgia, and Kazakhstan. The overall time to participate in this study is 25 to 26 weeks. Participants will make multiple visits to the clinic, and 12 weeks after last dose of study drug for a follow-up assessment.

Conditions

• Peripheral Arterial Diseases

Interventions

Type	Name	Description
DRUG	Actovegin	Actovegin intravenous infusion and tablets.
DRUG	Placebo	Actovegin placebo-matching intravenous infusion and tablets.

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-05-28
• Completion: 2019-08-28
• First posted: 2018-03-19
• Last updated: 2020-10-28
• Results posted: 2020-10-28

Locations

20 sites across 3 countries: Georgia, Kazakhstan, Russia