The purpose of the study is to evaluate the efficacy and safety of actovegin in participants with peripheral arterial disease (PAD) Fontaine Stage IIB.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
366
Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12
ICD was the distance walked at the onset of claudication pain or pain-free walking distance. ICD was assessed using treadmill testing. A fixed load treadmill test was carried out at 3.0 kilometer per hour (km/h) with a 10 percent (%) grade.
Time frame: Baseline up to Week 12
Percent Change From Baseline in ICD at Weeks 2 and 24
ICD was the distance walked at the onset of claudication pain or pain-free walking distance. ICD was assessed using treadmill testing. A fixed load treadmill test was carried out at 3.0 km/h with a 10% grade.
Time frame: Baseline up to Weeks 2 and 24
Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24
ACD was the distance at which claudication pain becomes so severe that the participant was forced to stop, also known as maximal walking distance. ACD was assessed using treadmill testing. A fixed load treadmill test was carried out at 3.0 km/h with a 10% grade. The investigator will record the distance from walking start to the point where the participant is unable to walk anymore.
Time frame: Baseline, Weeks 2, 12 and 24
Percentage of Participants With Rest Pain at Weeks 12 and 24
Rest pain was defined as a continuous burning pain, that begins, or is aggravated, after reclining or elevating the limb and is relieved by sitting or standing.
Time frame: Weeks 12 and 24
Percentage of Participants With Revascularization Procedures at Week 24
Revascularization was defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores were used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.
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Center of Vascular and Heart Disease
Tbilisi, Georgia
Aversi Clinic
Tbilisi, Georgia
"National scientific centre of oncology and transplantology"
Astana, Kazakhstan
Regional Clinic Hospital
Shymkent, Kazakhstan
NSHI Road clinical hospital at Chelyabinsk station of OAO RZD
Chelyabinsk, Russia
Federal state budgetary research institution Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, Russia
BMH Kursk regional clinical hospital of Healthcare department of Kursk region
Kursk, Russia
SBHI of Moscow city "City clinical hospital #29 n.a. N.E. Bauman of Moscow Healthcare department
Moscow, Russia
SBHI of Moscow healthcare department City clinical hospital #15 n.a. O.M Filatov of Moscow healthcare department
Moscow, Russia
SBHI of Moscow Research Institute of Emergency Medicine n.a. N.V. Sklifosofsky of Moscow Healthcare department
Moscow, Russia
...and 10 more locations
Time frame: Week 24
Change From Baseline in 36-Item Short Form Survey (SF-36) at Weeks 12 and 24
The SF-36 was a questionnaire that evaluated a participant's health related quality of life. SF-36 included 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical health score was generated which ranges between 0 and 100, with higher scores indicating a better quality of life. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental health score was generated which ranges between 0 and 100, with higher scores indicating a better quality of life.
Time frame: Baseline, Weeks 12 and 24