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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 366
- Locations
- 20
- Primary Endpoint
- Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12
Study Overview
Brief 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:
- Actovegin
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has a history of stable intermittent claudication lasting more than 6 months before Screening.
- •Has a diagnosis of peripheral arterial disease (PAD) (Code I70.2 according to the international classification of diseases-10th revision) Fontaine Stage IIB confirmed by ultrasound color duplex imaging.
- •Has a resting Doppler ankle-brachial index of less than or equal to (<=) 0.
- •Has intermittent claudication with initial claudication distance (ICD) less than (<) 200 meters.
- •Is not newly diagnosed with PAD and has a history of stable PAD therapy for at least 2 weeks before Screening.
Exclusion Criteria
- •Has PAD Fontaine Stage III or IV (pain at rest, non-healing ulceration, or gangrene).
- •Has evidence of nonatherosclerotic PAD.
- •Has greater than (>) 25 percent (%) variability in absolute claudication distance (ACD) based on treadmill testing during the screening period.
- •Has lower extremity arterial reconstruction (surgical or endovascular) or sympathectomy within 3 months before Screening.
- •Is eligible for surgical/interventional reconstruction.
- •Had a myocardial infarction or major cardiac surgery within 3 months before Screening.
- •Has congestive heart failure (New York Heart Association Class III/IV).
- •Has uncontrolled diabetes mellitus (glycosylated hemoglobin [HbA1c >9%]) or diabetic polyneuropathy.
- •Has any other illness that significantly limits exercise capacity or other medical condition, including any psychiatric disorder that limits participation (in the judgement of the investigator).
- •The subject has received any prohibited medication within 14 days before Randomization (Day 1)
- •The subject is undergoing the supervised exercise training program by the time of Screening and is going to continue this program due to its effectiveness.
Arms & Interventions
Actovegin 1200 mg
Actovegin 1200 milligram (mg), intravenously, once daily for up to 2 weeks followed by actovegin 200 mg, tablets, orally, thrice daily (TID) (1200 mg/day) for up to 10 weeks.
Intervention: Actovegin (Drug)
Placebo
Actovegin placebo-matching, intravenously, once daily for up to 2 weeks and actovegin placebo-matching tablets, orally, TID for up to 10 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12
Time Frame: Baseline up to 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.
Secondary Outcomes
- Percentage of Participants With Rest Pain at Weeks 12 and 24(Weeks 12 and 24)
- Percentage of Participants With Revascularization Procedures at Week 24(Week 24)
- Percent Change From Baseline in ICD at Weeks 2 and 24(Baseline up to Weeks 2 and 24)
- Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24(Baseline, Weeks 2, 12 and 24)
- Change From Baseline in 36-Item Short Form Survey (SF-36) at Weeks 12 and 24(Baseline, Weeks 12 and 24)